Home NDC 57664-025 Isotretinoin
Product NDC 57664-025
11-digit product format 576640025
Labeler code 57664
Product ID 57664-025_0e924cf6-5375-28c4-e063-6294a90a4ac4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isotretinoin
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA021951
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-12-29
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 42 .
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 N021951-001 ABSORICA ISOTRETINOIN 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 N021951-002 ABSORICA ISOTRETINOIN 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 N021951-003 ABSORICA ISOTRETINOIN 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 N021951-004 ABSORICA ISOTRETINOIN 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 N021951-005 ABSORICA ISOTRETINOIN 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 N021951-006 ABSORICA ISOTRETINOIN 35MG CAPSULE / ORAL AB2 RLD 2014-08-15
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 7 · 252 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 2026-08-18 06:07:40 2026-07 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021951-005 ABSORICA 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021951-006 ABSORICA 35MG CAPSULE / ORAL AB2 RLD 2014-08-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021951-005 ABSORICA 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021951-006 ABSORICA 35MG CAPSULE / ORAL AB2 RLD 2014-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021951-005 ABSORICA 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021951-006 ABSORICA 35MG CAPSULE / ORAL AB2 RLD 2014-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021951-005 ABSORICA 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021951-006 ABSORICA 35MG CAPSULE / ORAL AB2 RLD 2014-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021951-005 ABSORICA 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021951-006 ABSORICA 35MG CAPSULE / ORAL AB2 RLD 2014-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021951-005 ABSORICA 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021951-006 ABSORICA 35MG CAPSULE / ORAL AB2 RLD 2014-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 238 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 270 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021951-001 7435427 2021-09-21 Drug product 2012-06-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-001 8367102 2021-09-21 U-1347 2013-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-001 8952064 2021-09-21 Drug product 2015-02-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-001 9078925 2021-09-21 Drug product 2015-07-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-001 9089534 2021-09-21 Drug product 2015-09-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-002 7435427 2021-09-21 Drug product 2012-06-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-002 8367102 2021-09-21 U-1347 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-002 8952064 2021-09-21 Drug product 2015-02-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-002 9078925 2021-09-21 Drug product 2015-07-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-002 9089534 2021-09-21 Drug product 2015-09-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-003 7435427 2021-09-21 Drug product 2012-06-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-003 8367102 2021-09-21 U-1347 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-003 8952064 2021-09-21 Drug product 2015-02-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-003 9078925 2021-09-21 Drug product 2015-07-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-003 9089534 2021-09-21 Drug product 2015-09-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-004 7435427 2021-09-21 Drug product 2012-06-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-004 8367102 2021-09-21 U-1347 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-004 8952064 2021-09-21 Drug product 2015-02-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-004 9078925 2021-09-21 Drug product 2015-07-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-004 9089534 2021-09-21 Drug product 2015-09-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-005 7435427 2021-09-21 Drug product 2015-04-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-005 8367102 2021-09-21 U-1347 2015-04-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-005 8952064 2021-09-21 Drug product 2015-02-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-005 9078925 2021-09-21 Drug product 2015-07-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-005 9089534 2021-09-21 Drug product 2015-09-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-006 7435427 2021-09-21 Drug product 2015-04-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-006 8367102 2021-09-21 U-1347 2015-04-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-006 8952064 2021-09-21 Drug product 2015-02-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-006 9078925 2021-09-21 Drug product 2015-07-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021951-006 9089534 2021-09-21 Drug product 2015-09-17 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021951-001 7435427 2021-09-21 Drug product 2012-06-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-001 8367102 2021-09-21 U-1347 2013-02-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-001 8952064 2021-09-21 Drug product 2015-02-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-001 9078925 2021-09-21 Drug product 2015-07-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-001 9089534 2021-09-21 Drug product 2015-09-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-002 7435427 2021-09-21 Drug product 2012-06-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-002 8367102 2021-09-21 U-1347 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-002 8952064 2021-09-21 Drug product 2015-02-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-002 9078925 2021-09-21 Drug product 2015-07-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021951-002 9089534 2021-09-21 Drug product 2015-09-17 782e0a99824c…
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 57664-025-97 Isotretinoin 3 in 1 BOX CAPSULE 3 2 57664-025-98 Isotretinoin 10 in 1 BLISTER PACK CAPSULE 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-025 ISOTRETINOIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240110_b44200ba-6672-4ea7-b151-7caec3f53c9c.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 · 2 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 57664-025-97 57664002597 3 BLISTER PACK in 1 BOX (57664-025-97) / 10 CAPSULE in 1 BLISTER PACK (57664-025-98) 3 blister pack 2020-12-29 0000-00-00 No No Current 57664-025-98 57664002598 10 in 1 BLISTER PACK Historical