NDC Code(s) : 43598-224-14, 43598-224-01, 43598-224-05, 43598-219-14, 43598-219-01, 43598-223-50, 43598-223-51, 43598-223-52, 43598-207-50, 43598-207-51, 43598-207-52
Packager : Dr Reddys Laboratories Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AMOXICILLINamoxicillin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-224
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
D&C RED NO. 30(UNII: 2S42T2808B)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 17 mm
Flavor Imprint Code AMOXIL;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-224-1420 in 1 BOTTLE Type 0: Not a Combination Product07/10/1978
2NDC:43598-224-01100 in 1 BOTTLE Type 0: Not a Combination Product07/10/1978
3NDC:43598-224-05500 in 1 BOTTLE Type 0: Not a Combination Product07/10/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050754 07/10/1978
AMOXICILLINamoxicillin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-219
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS875 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
D&C RED NO. 30(UNII: 2S42T2808B)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score 2 pieces
Shape CAPSULE Size 20 mm
Flavor Imprint Code AMOXIL;875
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-219-1420 in 1 BOTTLE Type 0: Not a Combination Product07/10/1978
2NDC:43598-219-01100 in 1 BOTTLE Type 0: Not a Combination Product07/10/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050754 07/10/1978
AMOXICILLINamoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-223
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS200 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:43598-223-5050 mL in 1 BOTTLE Type 0: Not a Combination Product15/04/1999
2NDC:43598-223-5175 mL in 1 BOTTLE Type 0: Not a Combination Product15/04/1999
3NDC:43598-223-52100 mL in 1 BOTTLE Type 0: Not a Combination Product15/04/1999
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050760 04/15/1999
AMOXICILLINamoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-207
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM(UNII: 9NEZ333N27)0.19 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:43598-207-5050 mL in 1 BOTTLE Type 0: Not a Combination Product15/04/1999
2NDC:43598-207-5175 mL in 1 BOTTLE Type 0: Not a Combination Product15/04/1999
3NDC:43598-207-52100 mL in 1 BOTTLE Type 0: Not a Combination Product15/04/1999
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050760 04/15/1999

PRINCIPAL DISPLAY PANEL

NDC 43598-224-01

100 Tablets

AMOXICILLIN

TABLETS

Each Tablet contains 500 mg amoxicillin as the trihydrate.

500 mg

Rx Only

Use only if inner seal is intact.
Store at or below 25°C (77°F).

Dispense in a tight container.

Each tablet contains 500 mg amoxicillin as the trihydrate.

Usual Dosage: 1 tablet every 12 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

I0414

150055375

Principle Display Panel

PRINCIPAL DISPLAY PANEL

NDC 43598-219-01

100 Tablets

AMOXICILLIN

TABLETS

Each Tablet contains 875 mg amoxicillin as the trihydrate

875 mg

Rx Only

Use only if inner seal is intact.
Store at or below 25°C (77°F). Dispense in a tight container.
Each tablet contains 875 mg amoxicillin as the trihydrate.

Usual Dosage: 1 tablet every 12 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

I0414

150055373

Principle Display Panel

PRINCIPAL DISPLAY PANEL

NDC 43598-223-50

200 mg/5 mL

AMOXICILLIN

FOR ORAL SUSPENSION

When reconstituted, each 5mL contains 200 mg amoxicillin as the trihydrate.

50 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=39 mL); shake vigorously to wet powder. Add remaining water; again shake vigorously. Each 5 mL (1 teaspoonful) will contain amoxicillin trihydrate equivalent to 200 mg amoxicillin.

Dosage: Administer every 12 hours.
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 2.0 grams amoxicillin.
Store dry powder at or below 25°C (77°F).

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

I0414

150055388

Principle Display Panel

PRINCIPAL DISPLAY PANEL

NDC 43598-207-50

400 mg/5 mL

AMOXICILLIN

FOR ORAL SUSPENSION

When reconstituted, each 5mL contains 400 mg amoxicillin as the trihydrate.

50 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=36 mL); shake vigorously to wet powder. Add remaining water; again shake vigorously. Each 5 mL (1 teaspoonful) will contain amoxicillin trihydrate equivalent to 400 mg amoxicillin.


Dosage: Administer every 12 hours.
See accompanying prescribing information.

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

Net contents: Equivalent to 4.0 grams amoxicillin.
Store dry powder at or below 25°C (77°F).

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

I0414

150055371

Principle Display Panel