Amlodipine Besylate: Package Insert and Label Information (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMLODIPINE BESYLATE TABLETS USP

Rx only

2.5 mg

NDC 68180-750-09

90 Tablets

old-2.5 mg
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

2.5 mg

NDC 68180-719-09

90 Tablets

Image05
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

5 mg

NDC 68180-751-09

90 Tablets

old-5mg
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

5 mg

NDC 68180-720-09

90 Tablets

image-06
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

10 mg

NDC 68180-752-09

90 Tablets

old-10mg
(click image for full-size original)

AMLODIPINE BESYLATE TABLETS USP

Rx Only

10 mg

NDC 68180-721-09

90 Tablets

image-07
(click image for full-size original)
AMLODIPINE BESYLATE amlodipine 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 (AMLODIPINE) AMLODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape DIAMOND (Diamond) Size 8mm
Flavor Imprint Code LU;H11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-750-09 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007 06/30/2021
AMLODIPINE BESYLATE amlodipine 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 (AMLODIPINE) AMLODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape OCTAGON (8 SIDED) (Elongated octagon) Size 9mm
Flavor Imprint Code LU;H12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-751-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-751-17 300 TABLET in 1 BOTTLE None
3 NDC:68180-751-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007 07/31/2021
AMLODIPINE BESYLATE amlodipine 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 (AMLODIPINE) AMLODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Round) Size 11mm
Flavor Imprint Code LU;H13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-752-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-752-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/03/2007 06/30/2021
AMLODIPINE BESYLATE amlodipine 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 (AMLODIPINE) AMLODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
FD&C RED NO. 40
MAGNESIUM STEARATE
POVIDONE
SILICON DIOXIDE
Product Characteristics
Color PINK (pink color mottled) Score no score
Shape ROUND (Flat-faced, beveled edged) Size 7mm
Flavor Imprint Code L;28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-719-09 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 10/31/2018
AMLODIPINE BESYLATE amlodipine 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 (AMLODIPINE) AMLODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE
SILICON DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 8mm
Flavor Imprint Code L;29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-720-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-720-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078043 08/15/2018
AMLODIPINE BESYLATE amlodipine 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 (AMLODIPINE) AMLODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
POVIDONE
SILICON DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (Flat faced, beveled edged) Size 7mm
Flavor Imprint Code L;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-721-09 90 TABLET in 1 BOTTLE None
2 NDC:68180-721-03 1000 TABLET in 1 BOTTLE None
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 Operations
LUPIN LIMITED 677600414 MANUFACTURE (68180-750), MANUFACTURE (68180-751), MANUFACTURE (68180-752), PACK (68180-750), PACK (68180-751), PACK (68180-752)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 862272739 MANUFACTURE (68180-750), MANUFACTURE (68180-751), MANUFACTURE (68180-752), MANUFACTURE (68180-719), MANUFACTURE (68180-720), MANUFACTURE (68180-721), PACK (68180-750), PACK (68180-751), PACK (68180-752), PACK (68180-719), PACK (68180-720), PACK (68180-721)

Revised: 05/2021 Lupin Pharmaceuticals, Inc.

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