NDC Code(s) : 68180-750-09, 68180-751-09, 68180-751-03, 68180-751-17, 68180-752-09, 68180-752-03, 68180-719-09, 68180-719-03, 68180-720-09, 68180-720-03, 68180-721-09, 68180-721-03
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-750
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE2.5 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape DIAMOND (Diamond) Size 8 mm
Flavor Imprint Code LU;H11
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-750-0990 in 1 BOTTLE Type 0: Not a Combination Product08/03/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007 06/30/2021
Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-751
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape OCTAGON (8 SIDED) (Elongated octagon) Size 9 mm
Flavor Imprint Code LU;H12
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-751-0990 in 1 BOTTLE Type 0: Not a Combination Product08/03/2007
2NDC:68180-751-031000 in 1 BOTTLE Type 0: Not a Combination Product08/03/2007
3NDC:68180-751-17300 in 1 BOTTLE Type 0: Not a Combination Product01/01/2040
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007
Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-752
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Round) Size 11 mm
Flavor Imprint Code LU;H13
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-752-0990 in 1 BOTTLE Type 0: Not a Combination Product08/03/2007
2NDC:68180-752-031000 in 1 BOTTLE Type 0: Not a Combination Product08/03/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007 06/30/2021
Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-719
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C RED NO. 40(UNII: WZB9127XOA)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color PINK (pink color mottled) Score no score
Shape ROUND (Flat-faced, beveled edged) Size 7 mm
Flavor Imprint Code L;28
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-719-0990 in 1 BOTTLE Type 0: Not a Combination Product31/10/2018
2NDC:68180-719-031000 in 1 BOTTLE Type 0: Not a Combination Product01/01/2040
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 10/31/2018
Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-720
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 8 mm
Flavor Imprint Code L;29
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-720-0990 in 1 BOTTLE Type 0: Not a Combination Product15/08/2018
2NDC:68180-720-031000 in 1 BOTTLE Type 0: Not a Combination Product31/10/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/15/2018
Amlodipine BesylateAmlodipine Besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-721
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Flat faced, beveled edged) Size 7 mm
Flavor Imprint Code L;32
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-721-0990 in 1 BOTTLE Type 0: Not a Combination Product15/08/2018
2NDC:68180-721-031000 in 1 BOTTLE Type 0: Not a Combination Product23/10/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/15/2018

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 677600414 MANUFACTURE(68180-750, 68180-751, 68180-752), PACK(68180-750, 68180-751, 68180-752)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 862272739 MANUFACTURE(68180-750, 68180-751, 68180-752, 68180-719, 68180-720, 68180-721), PACK(68180-750, 68180-751, 68180-752, 68180-719, 68180-720, 68180-721)

PRINCIPAL DISPLAY PANEL

AMLODIPINE BESYLATE TABLETS USP

Rx only

2.5 mg

NDC 68180-750-09

90 Tablets

old-2.5 mg

AMLODIPINE BESYLATE TABLETS USP

Rx Only

2.5 mg

NDC 68180-719-09

90 Tablets

 

old-2.5 mg

AMLODIPINE BESYLATE TABLETS USP

Rx Only

5 mg

NDC 68180-751-09

90 Tablets

old-2.5 mg

AMLODIPINE BESYLATE TABLETS USP

Rx Only

5 mg

NDC 68180-720-09

90 Tablets

 

old-2.5 mg

AMLODIPINE BESYLATE TABLETS USP

Rx Only

10 mg

NDC 68180-752-09

90 Tablets

old-2.5 mg

AMLODIPINE BESYLATE TABLETS USP

Rx Only

10 mg

NDC 68180-721-09

90 Tablets

 

old-2.5 mg