Amlodipine Besylate

AMLODIPINE BESYLATE- amlodipine besylate tablet
Zydus Lifesciences Limited

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-620-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 2.5 mg

Rx only

90 tablets

Amlodipine Besylate Tablets USP, 2.5 mg
(click image for full-size original)

NDC 65841-621-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 5 mg

Rx only

90 tablets

Amlodipine Besylate Tablets USP, 5 mg
(click image for full-size original)

NDC 65841-622-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 10 mg

Rx only

90 tablets

Amlodipine Besylate Tablets USP, 10 mg
(click image for full-size original)
AMLODIPINE BESYLATE
amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-620
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
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 4mm
Flavor Imprint Code Z;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-620-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-620-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-620-05 500 TABLET in 1 BOTTLE None
4 NDC:65841-620-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-620-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078226 09/21/2007
AMLODIPINE BESYLATE
amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-621
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
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code Z;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-621-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-621-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-621-05 500 TABLET in 1 BOTTLE None
4 NDC:65841-621-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-621-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078226 09/21/2007
AMLODIPINE BESYLATE
amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-622
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
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code Z;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-622-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-622-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-622-05 500 TABLET in 1 BOTTLE None
4 NDC:65841-622-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-622-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078226 09/21/2007
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 677605858 ANALYSIS (65841-620), ANALYSIS (65841-621), ANALYSIS (65841-622), MANUFACTURE (65841-620), MANUFACTURE (65841-621), MANUFACTURE (65841-622)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (65841-620), ANALYSIS (65841-621), ANALYSIS (65841-622), MANUFACTURE (65841-620), MANUFACTURE (65841-621), MANUFACTURE (65841-622)

Revised: 09/2023 Zydus Lifesciences Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.