Acyclovir

Product NDC: 67296-2162
11-digit product format: 672962162
Labeler code: 67296
Product ID: 67296-2162_45d25f9e-f166-7b35-e063-6294a90ac614
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA210401
Marketing category: ANDA
Marketing start: 2023-06-20
Substance: ACYCLOVIR
Active strength: 400 mg/1
Pharmacologic classes: DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	400 mg/1

Field, Values table
Field	Values
Unii	X4HES1O11F
Rxcui	197311

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33190c02-82e1-0a4d-d716-9ccd23588463	Product name	5	20250225
c367d1da-5a72-8966-6d11-1eb9a73ae758	Product name	3	20231115
5518bf13-db2f-2e9c-3679-e70ecf03752c	Product name	9	20210614
27897900-0e40-497b-97e1-88057e68fe6c	Product name	4	20200710
ca834e59-e669-229c-9288-0ccb76dc373e	Product name	9	20200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28	Product name	1	20190702
fb15b394-3715-4c87-a447-421489aa8739	Product name	3	20170727
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-2162-2	Acyclovir	20 in 1 BOTTLE	TABLET	20		3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4HES1O11F	ACYCLOVIR	59277-89-3	ACYCLOVIR

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197311	acyclovir 400 MG Oral Tablet	PSN	37453bcd-e34e-5902-e063-6294a90a0245	3
197311	acyclovir 400 MG Oral Tablet	SCD	37453bcd-e34e-5902-e063-6294a90a0245	3
197311	acycycloguanosine 400 MG Oral Tablet	SY	37453bcd-e34e-5902-e063-6294a90a0245	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2162-2	67296216202	20 TABLET in 1 BOTTLE (67296-2162-2)	20 tablet	2023-06-20	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg	Redpharm Drug	2025-12-13	HUMAN PRESCRIPTION DRUG LABEL	3