Amiodarone Hydrochloride

AMIODARONE HYDROCHLORIDE — amiodarone hydrochloride tablet
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-840-06

Amiodarone Hydrochloride Tablets USP, 100 mg

30 Tablets

Rx only

100 mg label
(click image for full-size original)

NDC 65841-631-14 in bottle of 60 tablets

Amiodarone Hydrochloride Tablets, 200 mg

Rx only

Amiodarone Hydrochloride Tablets, 200 mg
(click image for full-size original)

NDC 65841-841-06

Amiodarone Hydrochloride Tablets USP, 400 mg

30 Tablets

Rx only

400 mg label
(click image for full-size original)
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-840
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
STARCH, CORN
Product Characteristics
Color WHITE (OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 297
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-840-06 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079029 02/09/2023
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-631
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code ZE;65
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-631-06 30 TABLET in 1 BOTTLE None
2 NDC:65841-631-14 60 TABLET in 1 BOTTLE None
3 NDC:65841-631-05 500 TABLET in 1 BOTTLE None
4 NDC:65841-631-10 1000 TABLET in 1 BOTTLE None
5 NDC:65841-631-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65841-631-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079029 08/10/2009
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-841
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 400 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
ALUMINUM OXIDE
STARCH, CORN
POVIDONE
D&C YELLOW NO. 10
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (PALE YELLOW TO YELLOW) Score 2 pieces
Shape ROUND (ROUND) Size 13mm
Flavor Imprint Code 2;98
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-841-06 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079029 02/09/2023
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (65841-631), ANALYSIS (65841-840), ANALYSIS (65841-841), MANUFACTURE (65841-631), MANUFACTURE (65841-840), MANUFACTURE (65841-841)

Revised: 01/2023 Zydus Lifesciences Limited

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