Home NDC 0591-2436 Isotretinoin
Product NDC 0591-2436
11-digit product format 005912436
Labeler code 0591
Product ID 0591-2436_2f164fd8-4912-4149-9292-0dc2249a69a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isotretinoin
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA205063
Marketing category ANDA
Marketing start 2021-04-29
Substance ISOTRETINOIN
Active strength 40 mg/1
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205063-001 ISOTRETINOIN ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-03-31 A205063-002 ISOTRETINOIN ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-03-31 A205063-003 ISOTRETINOIN ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2021-03-31 A205063-004 ISOTRETINOIN ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-03-31 A205063-005 ISOTRETINOIN ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2021-03-31 A205063-006 ISOTRETINOIN ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2021-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 6 · 204 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 A205063-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205063-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205063-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2021-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205063-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205063-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2021-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205063-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2021-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205063-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205063-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205063-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2021-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205063-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205063-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2021-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205063-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2021-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205063-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205063-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205063-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2021-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205063-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205063-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2021-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205063-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2021-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205063-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205063-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205063-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2021-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205063-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205063-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2021-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205063-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2021-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205063-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205063-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205063-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2021-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205063-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205063-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2021-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205063-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2021-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205063-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205063-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205063-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2021-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205063-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205063-005 ISOTRETINOIN 35MG CAPSULE / ORAL AB2 2021-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205063-006 ISOTRETINOIN 40MG CAPSULE / ORAL AB2 2021-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205063-001 ISOTRETINOIN 10MG CAPSULE / ORAL AB2 2021-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205063-002 ISOTRETINOIN 20MG CAPSULE / ORAL AB2 2021-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205063-003 ISOTRETINOIN 25MG CAPSULE / ORAL AB2 2021-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205063-004 ISOTRETINOIN 30MG CAPSULE / ORAL AB2 2021-03-31 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 204 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isotretinoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOTRETINOIN 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH28UP18IF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197843 Internal RxNorm lookup 197844 Internal RxNorm lookup 197845 Internal RxNorm lookup 403930 Internal RxNorm lookup 1547561 Internal RxNorm lookup 1547565 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 0591-2436-15 Isotretinoin 3 in 1 CARTON CAPSULE 3 20 0591-2436-45 Isotretinoin 10 in 1 BLISTER PACK CAPSULE 10 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2436 ISOTRETINOIN CAPSULE [ACTAVIS PHARMA, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20250524_1cf11710-f966-4529-8e08-02175f588bca.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 0591-2436-15 00591243615 3 BLISTER PACK in 1 CARTON (0591-2436-15) / 10 CAPSULE in 1 BLISTER PACK (0591-2436-45) 3 blister pack 2021-04-29 0000-00-00 No No Current 0591-2436-45 00591243645 10 in 1 BLISTER PACK Historical