Home DailyMed 4e9d42b1-13b6-41e0-afe4-661e3024e129 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:42:30 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 264 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 2026-10-15 13:18:30 2026-09 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021951-005 ABSORICA 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021951-006 ABSORICA 35MG CAPSULE / ORAL AB2 RLD 2014-08-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021951-001 ABSORICA 10MG CAPSULE / ORAL AB2 RLD 2012-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021951-002 ABSORICA 20MG CAPSULE / ORAL AB2 RLD 2012-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021951-003 ABSORICA 30MG CAPSULE / ORAL AB2 RLD 2012-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021951-004 ABSORICA 40MG CAPSULE / ORAL AB2 RLD, RS 2012-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021951-005 ABSORICA 25MG CAPSULE / ORAL AB2 RLD 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021951-006 ABSORICA 35MG CAPSULE / ORAL AB2 RLD 2014-08-15 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 250 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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.