Home NDC 62332-808 Tretinoin
Product NDC 62332-808
11-digit product format 623320808
Labeler code 62332
Product ID 62332-808_19550b32-7187-4836-8a6e-20b6f7e000bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tretinoin
Dosage form CREAM
Route TOPICAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA214590
Marketing category ANDA
Marketing start 2026-06-11
Substance TRETINOIN
Active strength .5 mg/g
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A214590-001 TRETINOIN TRETINOIN 0.05% CREAM / TOPICAL AB1 2026-06-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214590-001 AB1
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 2026-09-14 22:38:34 2026-08 A214590-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2026-06-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214590-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2026-06-11 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214590-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2026-06-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A214590-001 AB1 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214590-001 AB1 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214590-001 AB1 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tretinoin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRETINOIN .5 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 106303 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62332-808-20 62332080820 1 TUBE in 1 CARTON (62332-808-20) / 20 g in 1 TUBE 1 tube 2026-06-11 No No Current 62332-808-45 62332080845 1 TUBE in 1 CARTON (62332-808-45) / 45 g in 1 TUBE 1 tube 2026-06-11 No No Current