Home NDC 0187-0005 Altreno
Product NDC 0187-0005
11-digit product format 001870005
Labeler code 0187
Product ID 0187-0005_f942f9b5-aa0b-4729-98c5-76f50afcac88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tretinoin
Dosage form LOTION
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA209353
Marketing category NDA
Marketing start 2018-08-24
Substance TRETINOIN
Active strength .5 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 N209353-001 ALTRENO TRETINOIN 0.05% LOTION / TOPICAL RLD, RS 2018-08-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 N209353-001 11324710 2038-08-22 U-2368 2022-06-08
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 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209353-001 ALTRENO 0.05% LOTION / TOPICAL RLD, RS 2018-08-23 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209353-001 11324710 2038-08-22 U-2368 2022-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209353-001 6517847 2020-08-03 U-2368 Drug product 2018-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209353-001 6517847 2020-08-03 U-2368 Drug product 2018-08-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N209353-001 10653656 2038-08-22 U-2368 Drug product 2020-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209353-001 6517847 2020-08-03 U-2368 Drug product 2018-08-30 c0c555d07b60…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Altreno
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 250939 Internal RxNorm lookup 2055008 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 0187-0005 ALTRENO (TRETINOIN) LOTION [BAUSCH HEALTH US, LLC] 16 Current NDC, Legacy NDC, 10 package rows 20200620_1412aba5-71aa-4cce-8db4-c189bed1852c.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 0187-0005-03 00187000503 6 TUBE in 1 CARTON (0187-0005-03) / 3 g in 1 TUBE 6 tube 2018-08-24 0000-00-00 Yes No Current 0187-0005-04 00187000504 3 g in 1 TUBE 3 g Historical 0187-0005-10 00187000510 10 TUBE in 1 CARTON (0187-0005-10) / 3 g in 1 TUBE (0187-0005-04) 10 tube 2019-05-22 0000-00-00 Yes No Current 0187-0005-20 00187000520 1 TUBE in 1 CARTON (0187-0005-20) / 20 g in 1 TUBE 1 tube 2019-11-08 0000-00-00 No No Current 0187-0005-45 00187000545 1 TUBE in 1 CARTON (0187-0005-45) / 45 g in 1 TUBE 1 tube 2018-08-24 0000-00-00 No No Current 0187-0005-50 00187000550 1 BOTTLE, PUMP in 1 CARTON (0187-0005-50) / 50 g in 1 BOTTLE, PUMP 2019-04-13 0000-00-00 No No Current