Acyclovir

Product NDC: 62135-039
11-digit product format: 621350039
Labeler code: 62135
Product ID: 62135-039_458baf7d-dea5-aa22-e063-6394a90a8ae5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA212173
Marketing category: ANDA
Marketing start: 2021-03-12
Substance: ACYCLOVIR
Active strength: 200 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	200 mg/1

Field, Values table
Field	Values
Unii	X4HES1O11F
Rxcui	197310, 197313

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
62135-039-50	Acyclovir	50 in 1 BOTTLE	CAPSULE	50		4

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-039-50	EA - Each	62135-039	f2e21f05-03e0-4c93-84db-3d0c4b63cdbe	1	2022-09-12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-039	ACYCLOVIR CAPSULE ACYCLOVIR TABLET [CHARTWELL RX, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20241012_8cd22728-34b4-4e55-8339-580138fe46d8.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
197310	acyclovir 200 MG Oral Capsule	PSN	8cd22728-34b4-4e55-8339-580138fe46d8	4
197313	acyclovir 800 MG Oral Tablet	PSN	8cd22728-34b4-4e55-8339-580138fe46d8	4
197310	acyclovir 200 MG Oral Capsule	SCD	8cd22728-34b4-4e55-8339-580138fe46d8	4
197313	acyclovir 800 MG Oral Tablet	SCD	8cd22728-34b4-4e55-8339-580138fe46d8	4
197310	acycycloguanosine 200 MG Oral Capsule	SY	8cd22728-34b4-4e55-8339-580138fe46d8	4
197313	acycycloguanosine 800 MG Oral Tablet	SY	8cd22728-34b4-4e55-8339-580138fe46d8	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62135-039-50	62135003950	50 CAPSULE in 1 BOTTLE (62135-039-50)	50 capsule	2022-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 800 mg	Chartwell RX, LLC	2025-12-09	HUMAN PRESCRIPTION DRUG LABEL	4