Acyclovir

Product NDC: 67296-1089
11-digit product format: 672961089
Labeler code: 67296
Product ID: 67296-1089_d60fd320-eb37-4489-e053-2995a90a8432
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA203834
Marketing category: ANDA
Marketing start: 2013-11-29
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1089-2	2024-01-30	C162847	48780-1	1030e365-669d-111a-e063-dadaa90a10e2	4e7965f2-09ba-6f9a-e054-00144ff8d46c
67296-1089-5	2024-01-30	C162847	48780-1	1030e365-669d-111a-e063-dadaa90a10e2	4e7965f2-09ba-6f9a-e054-00144ff8d46c

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1089-2	Acyclovir	20 in 1 BOTTLE	TABLET	20		3
67296-1089-5	Acyclovir	15 in 1 BOTTLE	TABLET	15		3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1089	ACYCLOVIR TABLET [REDPHARM DRUG, INC.]	3	Legacy NDC, 2 package rows	20220121_4e7965f2-09ba-6f9a-e054-00144ff8d46c.zip

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	4e7965f2-09ba-6f9a-e054-00144ff8d46c	3
197311	acyclovir 400 MG Oral Tablet	SCD	4e7965f2-09ba-6f9a-e054-00144ff8d46c	3
197311	acycycloguanosine 400 MG Oral Tablet	SY	4e7965f2-09ba-6f9a-e054-00144ff8d46c	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1089-2	67296108902	20 TABLET in 1 BOTTLE (67296-1089-2)	20 tablet	2013-11-29	0000-00-00	No	No	Current
67296-1089-5	67296108905	15 TABLET in 1 BOTTLE (67296-1089-5)	15 tablet	2013-11-29	0000-00-00	No	No	Current