FDA.reportPublic FDA data

acyclovir

Product NDC
68382-125
Requested package NDC
68382-125-10
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68382-12568382-125-10DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206606-001ACYCLOVIR SODIUMACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13
A206606-002ACYCLOVIR SODIUMACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13a50c72e98297…
2026-08-01 22:54:322026-06A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13a50c72e98297…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-125ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]4Legacy NDC20221118_ca54c058-808e-4ad2-a33e-07796a4b27d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-125-106838201251010 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68382-125-10) 2017-08-170000-00-00NoNoCurrent