Home NDC 59651-713 Tretinoin
Product NDC 59651-713
11-digit product format 596510713
Labeler code 59651
Product ID 59651-713_50b05c90-bdd9-4766-b285-52bd88c4c740
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tretinoin
Dosage form GEL
Route TOPICAL
Labeler Aurobindo Pharma Limited
Application ANDA218245
Marketing category ANDA
Marketing start 2025-02-27
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 A218245-001 TRETINOIN TRETINOIN 0.025% GEL / TOPICAL AB 2025-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218245-001 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 A218245-001 TRETINOIN 0.025% GEL / TOPICAL AB 2025-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218245-001 TRETINOIN 0.025% GEL / TOPICAL AB 2025-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218245-001 TRETINOIN 0.025% GEL / TOPICAL AB 2025-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218245-001 TRETINOIN 0.025% GEL / TOPICAL AB 2025-02-27 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218245-001 TRETINOIN 0.025% GEL / TOPICAL AB 2025-02-27 a50c72e98297…
Observed Orange Book normalized TE history# 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 313451 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-713 TRETINOIN GEL [AUROBINDO PHARMA LIMITED] 2 Current NDC, 4 package rows 20250408_dea325b5-3cb8-4ffb-84e9-782f0e3f6b0e.zip
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 · 1 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 59651-713-14 59651071314 1 TUBE in 1 CARTON (59651-713-14) / 15 g in 1 TUBE 1 tube 2025-02-27 No No Current 59651-713-46 59651071346 1 TUBE in 1 CARTON (59651-713-46) / 45 g in 1 TUBE 1 tube 2025-02-27 No No Current