Prescription Drug Information: Acyclovir (Page 3 of 3)

PRINCIPAL DISPLAY PANEL

NDC 72241-026-05
ACYCLOVIR
TABLETS, USP
400 mg
Rx only 100 TABLETS

acyclovir-400mg-100tabs
(click image for full-size original)

NDC 72241-026-10
ACYCLOVIR
TABLETS, USP
400 mg
Rx only 500 TABLETS

acyclovir-400mg-500tabs
(click image for full-size original)

NDC 72241-027-05
ACYCLOVIR
TABLETS, USP
800 mg
Rx only 100 TABLETS

acyclovir-800mg-100tabs
(click image for full-size original)


NDC 72241-027-10
ACYCLOVIR
TABLETS, USP
800 mg

Rx only 500 TABLETS

acyclovir-800mg-500tabs
(click image for full-size original)

ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72241-026
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 400 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color BLUE (Light blue to blue) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code CP114;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72241-026-05 100 TABLET in 1 BOTTLE None
2 NDC:72241-026-10 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202168 08/18/2021
ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72241-027
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 800 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 2
POVIDONE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code CP113;800
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72241-027-05 100 TABLET in 1 BOTTLE None
2 NDC:72241-027-10 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202168 08/18/2021
Labeler — Modavar Pharmaceuticals LLC (858949204)
Establishment
Name Address ID/FEI Operations
Cadila Pharmaceuticals Limited 918451696 ANALYSIS (72241-026), ANALYSIS (72241-027), LABEL (72241-026), LABEL (72241-027), MANUFACTURE (72241-026), MANUFACTURE (72241-027), PACK (72241-026), PACK (72241-027)

Revised: 11/2021 Modavar Pharmaceuticals LLC

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