Home NDC 59212-601-22 PANRETIN
Product NDC 59212-601
Requested package NDC 59212-601-22
11-digit product format 592120601
Labeler code 59212
Product ID 59212-601_5b7465cd-3367-44ee-a11d-d021d6400a23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alitretinoin
Dosage form GEL
Route TOPICAL
Labeler Advanz Pharma (US) Corp.
Application NDA020886
Marketing category NDA
Marketing start 2019-09-10
Substance ALITRETINOIN
Active strength 60 mg/60g
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 N020886-001 PANRETIN ALITRETINOIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02
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.
Product history page 1 of 2 · 41 observed 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 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020886-001 PANRETIN EQ 0.1% BASE GEL / TOPICAL RLD, RS 1999-02-02 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base PANRETIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALITRETINOIN 60 mg/60g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1UA8E65KDZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213502 Internal RxNorm lookup 313847 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 59212-601-22 PANRETIN 60 g in 1 TUBE GEL 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59212-601 PANRETIN (ALITRETINOIN) GEL [ADVANZ PHARMA (US) CORP.] 5 Current NDC, Legacy NDC, 1 package rows 20250411_49c16717-7d86-4257-80c9-baa1417e5555.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 Marketing end Sample Exclude flag Status 59212-601-22 59212060122 60 g in 1 TUBE (59212-601-22) 60 g 2019-09-10 0000-00-00 No No Current