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

AMLODIPINE BESYLATE TABLETS USP

Rx Only

2.5 mg

NDC 68180-719-09

90 Tablets

AMLODIPINE BESYLATE TABLETS USP

Rx Only

5 mg

NDC 68180-751-09

90 Tablets

AMLODIPINE BESYLATE TABLETS USP

Rx Only

5 mg

NDC 68180-720-09

90 Tablets

AMLODIPINE BESYLATE TABLETS USP

Rx Only

10 mg

NDC 68180-752-09

90 Tablets

AMLODIPINE BESYLATE TABLETS USP

Rx Only

10 mg

NDC 68180-721-09

90 Tablets

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 2 NDC:68180-719-03 1000 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: 02/2022 Lupin Pharmaceuticals, Inc.