FDA.reportPublic FDA data

Acyclovir

Product NDC
68071-5157
Requested package NDC
68071-5157-3
11-digit product format
680715157
Labeler code
68071
Product ID
68071-5157_bbf60b5c-ebdd-6c46-e053-2995a90a7365
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206437
Marketing category
ANDA
Marketing start
2017-08-18
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
50 mg/g
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
2022-12-31
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 packagepackage68071-515768071-5157-3DDiscontinued 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206437-001ACYCLOVIRACYCLOVIR5%OINTMENT / TOPICAL2017-07-31

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 22:54:322026-06A206437-001ACYCLOVIR5%OINTMENT / TOPICAL2017-07-31a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5157-32024-06-20C16284748780-1f386c64a-1e8b-0266-e053-dadaa90a7c1aAcyclovir Ointment USP, 5% Rx only
68071-5157-32023-01-30C16284748780-1f386c64a-1e8b-0266-e053-dadaa90a7c1aAcyclovir Ointment USP, 5% Rx only

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5157-36807151570330 g in 1 BOX (68071-5157-3) 30 g2020-01-220000-00-00NoNoCurrent