acyclovir

Product NDC: 68382-125
11-digit product format: 683820125
Labeler code: 68382
Product ID: 68382-125_0ff593fa-7941-4ca2-a780-120a96b7217a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACYCLOVIR
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA206606
Marketing category: ANDA
Marketing start: 2017-08-17
Marketing end: 0000-00-00
Substance: ACYCLOVIR SODIUM
Active strength: 500 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68382-125		D	Discontinued by firm		2026-07-31
excluded package	package	68382-125	68382-125-10	D	Discontinued by firm		2026-07-31

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206606-001	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2017-06-13
A206606-002	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2017-06-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-125	ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]	4	Legacy NDC	20221118_ca54c058-808e-4ad2-a33e-07796a4b27d4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
927L42J563	ACYCLOVIR SODIUM	69657-51-8	ACYCLOVIR SODIUM
X4HES1O11F	ACYCLOVIR	59277-89-3	ACYCLOVIR

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-125-10	68382012510	10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68382-125-10)	2017-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir for Injection, USP	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-11-14	HUMAN PRESCRIPTION DRUG LABEL	4