ACYCLOVIR

Product NDC: 0904-5789
11-digit product format: 009045789
Labeler code: 0904
Product ID: 0904-5789_47ed6bd7-4c02-404c-baf2-8ad542eb36df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA075677
Marketing category: ANDA
Marketing start: 2006-03-20
Marketing end: 2026-08-31
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
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

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
0904-5789-61	ACYCLOVIR	100 in 1 CARTON	CAPSULE	100		9
0904-5789-61	ACYCLOVIR	1 in 1 BLISTER PACK	CAPSULE	1		9

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5789-61	EA - Each	0904-5789	30493d93-5f21-4bdd-9d75-71ce43c36de0	1	2013-10-17

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACYCLOVIR	ACTIVE INGREDIENT	X4HES1O11F	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
ACYCLOVIR	ACTIVE MOIETY	X4HES1O11F	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5789	ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]	7	Current NDC, Legacy NDC, 2 package rows	20241025_864d96b9-e2de-45a8-850b-6f7b72ceefe1.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	7484b631-18f9-440d-bb11-a44932fec6e7	15
197310	acyclovir 200 MG Oral Capsule	SCD	7484b631-18f9-440d-bb11-a44932fec6e7	15
197310	acycycloguanosine 200 MG Oral Capsule	SY	7484b631-18f9-440d-bb11-a44932fec6e7	15
197310	acyclovir 200 MG Oral Capsule	PSN	864d96b9-e2de-45a8-850b-6f7b72ceefe1	9
197310	acyclovir 200 MG Oral Capsule	SCD	864d96b9-e2de-45a8-850b-6f7b72ceefe1	9
197310	acycycloguanosine 200 MG Oral Capsule	SY	864d96b9-e2de-45a8-850b-6f7b72ceefe1	9

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5789-61	00904578961	100 BLISTER PACK in 1 CARTON (0904-5789-61) / 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2006-03-20	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR CAPSULES USP 200 mg	Major Pharmaceuticals	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	9
ACYCLOVIR CAPSULES USP 200 mg	Cardinal Health 107, LLC	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	15