NDC Code(s) : 43598-225-01, 43598-225-05, 43598-205-01, 43598-205-05, 43598-222-80, 43598-222-52, 43598-222-53, 43598-209-80, 43598-209-52, 43598-209-53
Packager : Dr Reddys Laboratories Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AMOXICILLINamoxicillin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-225
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (OPAQUE), PINK (OPAQUE) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code AMOXIL;250
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-225-01100 in 1 BOTTLE Type 0: Not a Combination Product08/02/1979
2NDC:43598-225-05500 in 1 BOTTLE Type 0: Not a Combination Product08/02/1979
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062216 08/02/1979
AMOXICILLINamoxicillin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-205
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE (OPAQUE), PINK (OPAQUE) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code AMOXIL;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-205-01100 in 1 BOTTLE Type 0: Not a Combination Product08/02/1979
2NDC:43598-205-05500 in 1 BOTTLE Type 0: Not a Combination Product08/02/1979
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062216 08/02/1979
AMOXICILLINamoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-222
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM(UNII: 9NEZ333N27)0.11 meq in 5 mL
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-222-8080 mL in 1 BOTTLE Type 0: Not a Combination Product27/11/1979
2NDC:43598-222-52100 mL in 1 BOTTLE Type 0: Not a Combination Product27/11/1979
3NDC:43598-222-53150 mL in 1 BOTTLE Type 0: Not a Combination Product27/11/1979
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062226 11/27/1979
AMOXICILLINamoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-209
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM(UNII: 9NEZ333N27)0.15 meq in 5 mL
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-209-8080 mL in 1 BOTTLE Type 0: Not a Combination Product27/11/1979
2NDC:43598-209-52100 mL in 1 BOTTLE Type 0: Not a Combination Product27/11/1979
3NDC:43598-209-53150 mL in 1 BOTTLE Type 0: Not a Combination Product27/11/1979
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062226 11/27/1979

PRINCIPAL DISPLAY PANEL

NDC 43598-225-01

100 Capsules

AMOXICILLIN

CAPSULES

Each capsule contains 250 mg amoxicillin as the trihydrate.

250 mg

Rx Only

Use only if inner seal is intact.
Store at or below 25ºC (77ºF).
Dispense in a tight container.

Each capsule contains 250 mg amoxicillin as the trihydrate.

Usual Dosage: 250 to 500 mg every 8 hours.
See accompanying prescribing information.

Important:Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.
Bristol, TN 37620

I0412

150039405

Amoxicillin Capsules Label Image - 250 mg, 100 capsules

PRINCIPAL DISPLAY PANEL

NDC 43598-205-05

500 Capsules

AMOXICILLIN

CAPSULES

Each capsule contains 500 mg amoxicillin as the trihydrate.

500 mg

Rx Only

Use only if inner seal is intact.
Store at or below 25ºC (77ºF).
Dispense in a tight container.

Each capsule contains 500 mg amoxicillin as the trihydrate.

Usual Dosage: 250 to 500 mg every 8 hours.
See accompanying prescribing information.

Important:Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.
Bristol, TN 37620

I0412

Amoxicillin Capsules Label Image - 500 mg, 500 capsules

150039404

PRINCIPAL DISPLAY PANEL

NDC 43598-222-52

125 mg/5 mL

AMOXICILLIN

FOR ORAL SUSPENSION

When reconstituted, each 5 mL contains 125 mg amoxicillin as the trihydrate.

100 mL (when reconstituted)

Rx only

Directions for mixing:

Tap bottle until all powder flows freely. Add approximately 1/3 total amount of water for reconstitution (total = 78 mL) shake vigorously to wet powder. Add remaining water; again shake vigorously. Each 5 mL (1 teaspoonful) will contain amoxicillin trihydrate equivalent to 125 mg amoxicillin.

Usual Adult Dosage: 250 to 500 mg every 8 hours.

Usual Child Dosage: 20 to 40 mg/kg/day in divided doses every 8 hours, depending on age, weight and infection severity. See accompanying prescribing information.

Keep tightly closed.
Shake well before using.
Refrigeration preferable but not required.
Discard suspension after 14 days.

Use only if inner seal is intact.

Net contents: Equivalent to 2.5 grams amoxicillin.

Store dry powder at 20ºC-25ºC (68ºF-77ºF).

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.
Bristol, TN 37620

I0412

150039959

Amoxicillin Powder for Oral Suspension Label Image - 125 mg/5 mL, 100 mL

PRINCIPAL DISPLAY PANEL

NDC 43598-209-80

250 mg/5 mL

AMOXICILLIN

FOR ORAL SUSPENSION

When reconstituted, each 5 mL contains 250 mg amoxicillin as the trihydrate.

80 mL (when reconstituted)

Rx only

Directions for mixing:

Tap bottle until all powder flows freely. Add approximately 1/3 total amount of water for reconstitution (total = 59 mL); shake vigorously to wet powder. Add remaining water; again shake vigorously. Each 5 mL (1 teaspoonful) will contain amoxicillin trihydrate equivalent to 250 mg amoxicillin.

Usual Adult Dosage: 250 to 500 mg every 8 hours.

Usual Child Dosage: 20 to 40 mg/kg/day in divided doses every 8 hours, depending on age, weight and infection severity. See accompanying prescribing information.

Use only if inner seal is intact.

Net contents: Equivalent to 4.0 grams amoxicillin.

Store dry powder at 20ºC-25ºC (68ºF-77ºF).

Keep tightly closed. Shake well before using.
Refrigeration preferable but not required.
Discard suspension after 14 days.

Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.
Bristol, TN 37620

I0512

150039961

Amoxicillin Powder for Oral Suspension Label Image - 250 mg/5 mL, 80 mL