Home NDC 63629-2328 Acyclovir
Product NDC 63629-2328
11-digit product format 636292328
Labeler code 63629
Product ID 63629-2328_ab4273c9-fceb-44f0-856c-eae25b50088b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form OINTMENT
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA201501
Marketing category ANDA
Marketing start 2020-01-30
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 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201501-001 ACYCLOVIR ACYCLOVIR 5% OINTMENT / TOPICAL AB 2020-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201501-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A201501-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2020-01-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A201501-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Acyclovir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X4HES1O11F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197312 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-2328-1 Acyclovir 15 g in 1 TUBE OINTMENT 15 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2328 ACYCLOVIR OINTMENT [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20240112_e2b2c88a-84d2-42e6-ad18-819f7e78dbd6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-2328-1 63629232801 15 g in 1 TUBE (63629-2328-1) 15 g 2021-04-19 0000-00-00 No No Current