acyclovir

Product NDC: 58118-0791
11-digit product format: 581180791
Labeler code: 58118
Product ID: 58118-0791_b01362ca-77a3-30b5-e053-2995a90aa8b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acyclovir
Dosage form: TABLET
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
Application: ANDA204314
Marketing category: ANDA
Marketing start: 2019-06-17
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: 2021-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58118-0791-8	2024-01-30	C162847	48780-1	1030e365-1a8d-111a-e063-dadaa90a10e2	5b02c785-bf44-4895-b2ae-5f4c88c361fc

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-0791	ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	3	Legacy NDC	20200925_5b02c785-bf44-4895-b2ae-5f4c88c361fc.zip

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58118-0791-8	58118079108	30 TABLET in 1 BLISTER PACK (58118-0791-8)	30 tablet	2019-06-17	0000-00-00	No	No	Current