Valacyclovir: Package Insert and Label Information

VALACYCLOVIR- valacyclovir hydrochloride tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-629-06 in bottle of 30 tablets

Valacyclovir Tablets USP, 500 mg

Rx only

30 tablets

Valacyclovir tablets
(click image for full-size original)

NDC 65841-630-06 in bottle of 30 tablets

Valacyclovir Tablets USP, 1 gram

Rx only

30 tablets

Valacyclovir tablets
(click image for full-size original)
VALACYCLOVIR
valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-629
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape OVAL (CAPSULE) Size 18mm
Flavor Imprint Code 500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-629-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-629-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-629-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-629-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-629-30)
4 NDC:65841-629-30 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-629-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079137 04/05/2018
VALACYCLOVIR
valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-630
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 1000 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE) Score 2 pieces
Shape OVAL (CAPSULE) Size 23mm
Flavor Imprint Code 1000
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-630-34 21 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-630-10 1000 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-630-06 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079137 04/05/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-629), ANALYSIS (65841-630), MANUFACTURE (65841-629), MANUFACTURE (65841-630)

Revised: 09/2020 Cadila Healthcare Limited

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.