Home NDC 46708-809 Tretinoin
Product NDC 46708-809
11-digit product format 467080809
Labeler code 46708
Product ID 46708-809_dc155719-fc32-4f08-a9db-b59da2f80759
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tretinoin
Dosage form CREAM
Route TOPICAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA218399
Marketing category ANDA
Marketing start 2025-08-16
Substance TRETINOIN
Active strength .25 mg/g
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
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 A218399-001 TRETINOIN TRETINOIN 0.025% CREAM / TOPICAL AB 2025-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218399-001 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 2026-02-19 14:30 UTC 2026-02 A218399-001 TRETINOIN 0.025% CREAM / TOPICAL AB 2025-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218399-001 TRETINOIN 0.025% CREAM / TOPICAL AB 2025-08-14 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218399-001 TRETINOIN 0.025% CREAM / TOPICAL AB 2025-08-14 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218399-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218399-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218399-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Tretinoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRETINOIN .25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5688UTC01R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106302 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 46708-809-20 Tretinoin 1 in 1 CARTON CREAM 1 1 46708-809-20 Tretinoin 20 g in 1 TUBE CREAM 20 1 46708-809-45 Tretinoin 45 g in 1 TUBE CREAM 45 1 46708-809-45 Tretinoin 1 in 1 CARTON CREAM 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-809-20 46708080920 1 TUBE in 1 CARTON (46708-809-20) / 20 g in 1 TUBE 1 tube 2025-08-16 No No Current 46708-809-45 46708080945 1 TUBE in 1 CARTON (46708-809-45) / 45 g in 1 TUBE 1 tube 2025-08-16 No No Current