Amlodipine Besylate (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Amlodipine Besylate

GENERIC: Amlodipine Besylate

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-421-01

STRENGTH: 2.5 mg

COLOR: White (White to off-white)

SHAPE: Triangle (Triangle-shaped, flat-beveled edge)

SCORE: no score

SIZE: 8 mm

IMPRINT: W;421

QTY: 90 Tablets

Label-2.5mg-90T
(click image for full-size original)

DRUG: Amlodipine Besylate

GENERIC: Amlodipine Besylate

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-422-04

STRENGTH: 5 mg

COLOR: White (White to off-white)

SHAPE: Capsule (Caplet, flat-beveled edge)

SCORE: no score

SIZE: 9 mm

IMPRINT: W;422

QTY: 100 Tablets

Label-5mg-100T
(click image for full-size original)

DRUG: Amlodipine Besylate

GENERIC: Amlodipine Besylate

DOSAGE: Tablets

ADMINSTRATION: Oral

NDC: 64679-423-02

STRENGTH: 10 mg

COLOR: White (White to off-white)

SHAPE: Round (Round, flat-beveled edge)

SCORE: no score

SIZE: 11 mm

IMPRINT: W423

QTY: 1000 Tablets

Label-10mg-1000T
(click image for full-size original)
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-421
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
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape TRIANGLE (triangle-shaped, flat-beveled edge) Size 8mm
Flavor Imprint Code W;421
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-421-01 90 TABLET in 1 BOTTLE None
2 NDC:64679-421-04 100 TABLET in 1 BOTTLE None
3 NDC:64679-421-02 1000 TABLET in 1 BOTTLE None
4 NDC:64679-421-03 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64679-421-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078500 09/06/2007
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-422
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
MANNITOL
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape CAPSULE (caplet, flat-beveled edge) Size 9mm
Flavor Imprint Code W;422
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-422-01 90 TABLET in 1 BOTTLE None
2 NDC:64679-422-04 100 TABLET in 1 BOTTLE None
3 NDC:64679-422-05 300 TABLET in 1 BOTTLE None
4 NDC:64679-422-02 1000 TABLET in 1 BOTTLE None
5 NDC:64679-422-03 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64679-422-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078500 09/06/2007
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-423
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
MANNITOL
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score no score
Shape ROUND (round, flat-beveled edge) Size 11mm
Flavor Imprint Code W;423
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-423-01 90 TABLET in 1 BOTTLE None
2 NDC:64679-423-04 100 TABLET in 1 BOTTLE None
3 NDC:64679-423-02 1000 TABLET in 1 BOTTLE None
4 NDC:64679-423-03 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64679-423-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078500 09/06/2007
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt USA LLC. (170508365)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 ANALYSIS (64679-421), ANALYSIS (64679-422), ANALYSIS (64679-423), MANUFACTURE (64679-421), MANUFACTURE (64679-422), MANUFACTURE (64679-423), LABEL (64679-421), LABEL (64679-422), LABEL (64679-423), PACK (64679-421), PACK (64679-422), PACK (64679-423)

Revised: 04/2018 Wockhardt USA LLC.

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