Absorica

Product NDC: 10631-117
11-digit product format: 106310117
Labeler code: 10631
Product ID: 10631-117_fba81535-0761-42a7-b422-338f8bd2cfc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isotretinoin
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA021951
Marketing category: NDA
Marketing start: 2012-06-08
Substance: ISOTRETINOIN
Active strength: 30 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
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.

Application-product, TE code table
Application-product	TE code
N021951-001	AB2
N021951-002	AB2
N021951-003	AB2
N021951-004	AB2
N021951-005	AB2
N021951-006	AB2

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 · 246 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	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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-005	ABSORICA	25MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-006	ABSORICA	35MG	CAPSULE / ORAL	AB2	RLD	2014-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021951-001	ABSORICA	10MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021951-002	ABSORICA	20MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021951-003	ABSORICA	30MG	CAPSULE / ORAL	AB2	RLD	2012-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021951-004	ABSORICA	40MG	CAPSULE / ORAL	AB2	RLD, RS	2012-05-25	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 232 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021951-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021951-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021951-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021951-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021951-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021951-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-005	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021951-006	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-005	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021951-006	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021951-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021951-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021951-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021951-004	AB2	1	`2680178bc6a6…`

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: Absorica
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOTRETINOIN	30 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 2 · 24 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
1299203	Internal RxNorm lookup
1300006	Internal RxNorm lookup
1300014	Internal RxNorm lookup
1300016	Internal RxNorm lookup
1547561	Internal RxNorm lookup
1547563	Internal RxNorm lookup
1547565	Internal RxNorm lookup
1547567	Internal RxNorm lookup
2262711	Internal RxNorm lookup
2262713	Internal RxNorm lookup
2262714	Internal RxNorm lookup
2262715	Internal RxNorm lookup
2262717	Internal RxNorm lookup
2262719	Internal RxNorm lookup
2262721	Internal RxNorm lookup
2262723	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3ef0cff8-19c1-4441-b780-fca6c7ee1615	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8300c0f6-79a4-735b-88ec-d781bfffdb10	Product name	5	20260305
644afe93-ba9b-4043-8e40-a9fe9af2d5d7	Product name	2	20250616
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
e5fedfa5-6b96-4769-872b-95d1e7f3a85a	Product name	1	20200415
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10631-117-31	Absorica	3 in 1 BOX	CAPSULE	3		18
10631-117-69	Absorica	10 in 1 BLISTER PACK	CAPSULE	10		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10631-117-31	EA - Each	10631-117	4e9d42b1-13b6-41e0-afe4-661e3024e129	1	2013-02-13
10631-117-69	EA - Each	10631-117	6a99efae-f431-4374-8de3-23d66ffab563	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10631-117	ABSORICA (ISOTRETINOIN) CAPSULE ABSORICA LD (ISOTRETINOIN) CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20231003_3ef0cff8-19c1-4441-b780-fca6c7ee1615.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Absorica LD	ISOTRETINOIN	Sun Pharmaceutical Industries, Inc.	3ef0cff8-19c1-4441-b780-fca6c7ee1615	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021951 application number: NDA021951 ndc (product): 10631-117
Isotretinoin	ISOTRETINOIN	Sun Pharmaceutical Industries, Inc.	b44200ba-6672-4ea7-b151-7caec3f53c9c	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021951 application number: NDA021951

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EH28UP18IF	ISOTRETINOIN	4759-48-2	ISOTRETINOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1299203	Absorica 10 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300006	Absorica 20 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547563	Absorica 25 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300014	Absorica 30 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547567	Absorica 35 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300016	Absorica 40 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262713	Absorica LD 16 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262715	Absorica LD 20 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262719	Absorica LD 24 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262723	Absorica LD 28 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262727	Absorica LD 32 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262731	Absorica LD 8 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
197843	ISOtretinoin 10 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
197844	ISOtretinoin 20 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547561	ISOtretinoin 25 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
403930	ISOtretinoin 30 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547565	ISOtretinoin 35 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
197845	ISOtretinoin 40 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262711	ISOtretinoin micronized 16 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262714	ISOtretinoin micronized 20 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262717	ISOtretinoin micronized 24 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262721	ISOtretinoin micronized 28 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262725	ISOtretinoin micronized 32 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262729	ISOtretinoin micronized 8 MG Oral Capsule	PSN	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1299203	isotretinoin 10 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300006	isotretinoin 20 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547563	isotretinoin 25 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300014	isotretinoin 30 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547567	isotretinoin 35 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300016	isotretinoin 40 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262713	Micronized isotretinoin 16 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262715	Micronized isotretinoin 20 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262719	Micronized isotretinoin 24 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262723	Micronized isotretinoin 28 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262727	Micronized isotretinoin 32 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262731	Micronized isotretinoin 8 MG Oral Capsule [Absorica]	SBD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
197843	isotretinoin 10 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
197844	isotretinoin 20 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547561	isotretinoin 25 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
403930	isotretinoin 30 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547565	isotretinoin 35 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
197845	isotretinoin 40 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262711	Micronized isotretinoin 16 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262714	Micronized isotretinoin 20 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262717	Micronized isotretinoin 24 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262721	Micronized isotretinoin 28 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262725	Micronized isotretinoin 32 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262729	Micronized isotretinoin 8 MG Oral Capsule	SCD	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1299203	Absorica 10 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300006	Absorica 20 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547563	Absorica 25 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300014	Absorica 30 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1547567	Absorica 35 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
1300016	Absorica 40 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262713	Absorica LD 16 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262715	Absorica LD 20 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262719	Absorica LD 24 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262723	Absorica LD 28 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262727	Absorica LD 32 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262731	Absorica LD 8 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262711	isotretinoin micronized 16 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262714	isotretinoin micronized 20 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262717	isotretinoin micronized 24 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262721	isotretinoin micronized 28 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262725	isotretinoin micronized 32 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262729	isotretinoin micronized 8 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262713	Micronized Absorica 16 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262715	Micronized Absorica 20 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262719	Micronized Absorica 24 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262723	Micronized Absorica 28 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262727	Micronized Absorica 32 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18
2262731	Micronized Absorica 8 MG Oral Capsule	SY	3ef0cff8-19c1-4441-b780-fca6c7ee1615	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10631-117-31	10631011731	3 BLISTER PACK in 1 BOX (10631-117-31) / 10 CAPSULE in 1 BLISTER PACK (10631-117-69)	3 blister pack	2012-06-08	0000-00-00	No	No	Current
10631-117-69	10631011769	10 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Absorica	Sun Pharmaceutical Industries, Inc. \| Galephar Pharmaceutical Research Inc. \| Ohm Laboratories Inc.	2026-06-25	HUMAN PRESCRIPTION DRUG LABEL	20