FDA.reportPublic FDA data

acyclovir

Product NDC
0168-0825
11-digit product format
001680825
Labeler code
0168
Product ID
0168-0825_ef887c98-21ef-41ab-b772-922b1d6a171c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA206633
Marketing category
ANDA
Marketing start
2016-05-11
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0168-0825DDiscontinued by firm2026-07-31
excluded packagepackage0168-08250168-0825-15DDiscontinued by firm2026-07-31
excluded packagepackage0168-08250168-0825-30DDiscontinued 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
A206633-001ACYCLOVIRACYCLOVIR5%OINTMENT / TOPICALAB2016-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A206633-001AB

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 22:54:322026-06A206633-001ACYCLOVIR5%OINTMENT / TOPICALAB2016-05-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206633-001AB1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0825-152024-06-04C16284748780-10191ceaa-6905-198a-e063-dbdaa90aec3efougera ® ACYCLOVIR OINTMENT USP 5%
0168-0825-302024-06-04C16284748780-10191ceaa-6905-198a-e063-dbdaa90aec3efougera ® ACYCLOVIR OINTMENT USP 5%
0168-0825-152023-07-28C16284748780-10191ceaa-6905-198a-e063-dbdaa90aec3efougera ® ACYCLOVIR OINTMENT USP 5%
0168-0825-302023-07-28C16284748780-10191ceaa-6905-198a-e063-dbdaa90aec3efougera ® ACYCLOVIR OINTMENT USP 5%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0825-15GM - Gram0168-0825b117c7fe-1554-429d-b29a-bed55a9d830e12017-03-06
0168-0825-30GM - Gram0168-08256645d95a-ec23-479f-a4c4-19769dc91b5e12017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0825-15001680825151 TUBE in 1 CARTON (0168-0825-15) > 15 g in 1 TUBE1 tube2016-11-010000-00-00NoNoCurrent
0168-0825-30001680825301 TUBE in 1 CARTON (0168-0825-30) > 30 g in 1 TUBE1 tube2016-05-110000-00-00NoNoCurrent