ACCUTANE

Product NDC: 72143-252
Requested package NDC: 72143-252-30
11-digit product format: 721430252
Labeler code: 72143
Product ID: 72143-252_499b3a69-1651-0f27-e063-6294a90a49eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ISOTRETINOIN
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: JG Pharma Inc.
Application: ANDA202099
Marketing category: ANDA
Marketing start: 2022-08-01
Substance: ISOTRETINOIN
Active strength: 20 mg/1
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202099-001	ZENATANE	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2013-03-25
A202099-002	ZENATANE	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2013-03-25
A202099-003	ZENATANE	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2013-03-25
A202099-004	ZENATANE	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2015-02-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A202099-001	AB1
A202099-002	AB1
A202099-003	AB1
A202099-004	AB1

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202099-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-004	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202099-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202099-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202099-003	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202099-004	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202099-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202099-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202099-003	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202099-004	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202099-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202099-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202099-003	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202099-004	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202099-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202099-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202099-003	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202099-004	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202099-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202099-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202099-003	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202099-004	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202099-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202099-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202099-003	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202099-004	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202099-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202099-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202099-003	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202099-004	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202099-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202099-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202099-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202099-004	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ACCUTANE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOTRETINOIN	20 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197843	Internal RxNorm lookup
197844	Internal RxNorm lookup
197845	Internal RxNorm lookup
206880	Internal RxNorm lookup
206883	Internal RxNorm lookup
206902	Internal RxNorm lookup
403930	Internal RxNorm lookup
2473107	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
5b524a51-a16b-496e-b764-11c98c479c36	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
72143-252-30	ACCUTANE	10 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	10		3
72143-252-30	ACCUTANE	3 in 1 CARTON	CAPSULE, GELATIN COATED	3		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72143-252-30	EA - Each	72143-252	cecf20e5-a9cd-47f8-9b85-47727497f724	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72143-252	ACCUTANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [JG PHARMA INC.]	2	Current NDC, Legacy NDC, 2 package rows	20231221_5b524a51-a16b-496e-b764-11c98c479c36.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZENATANE	ISOTRETINOIN	BluePoint Laboratories	486d4a4b-0de5-431a-bef7-dae6b0e4fa20	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202099 application number: ANDA202099
ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	5b524a51-a16b-496e-b764-11c98c479c36	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202099 application number: ANDA202099 ndc (package): 72143-252-30 ndc (product): 72143-252 ndc11 (package): 72143025230
ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	27b3cf26-f22e-5b70-1c24-009933b7c6ee	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202099 application number: ANDA202099

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
206880	ACCUTANE 10 MG Oral Capsule	PSN	5b524a51-a16b-496e-b764-11c98c479c36	3
206883	ACCUTANE 20 MG Oral Capsule	PSN	5b524a51-a16b-496e-b764-11c98c479c36	3
2473107	ACCUTANE 30 MG Oral Capsule	PSN	5b524a51-a16b-496e-b764-11c98c479c36	3
206902	ACCUTANE 40 MG Oral Capsule	PSN	5b524a51-a16b-496e-b764-11c98c479c36	3
197843	ISOtretinoin 10 MG Oral Capsule	PSN	5b524a51-a16b-496e-b764-11c98c479c36	3
197844	ISOtretinoin 20 MG Oral Capsule	PSN	5b524a51-a16b-496e-b764-11c98c479c36	3
403930	ISOtretinoin 30 MG Oral Capsule	PSN	5b524a51-a16b-496e-b764-11c98c479c36	3
197845	ISOtretinoin 40 MG Oral Capsule	PSN	5b524a51-a16b-496e-b764-11c98c479c36	3
206880	isotretinoin 10 MG Oral Capsule [Accutane]	SBD	5b524a51-a16b-496e-b764-11c98c479c36	3
206883	isotretinoin 20 MG Oral Capsule [Accutane]	SBD	5b524a51-a16b-496e-b764-11c98c479c36	3
2473107	isotretinoin 30 MG Oral Capsule [Accutane]	SBD	5b524a51-a16b-496e-b764-11c98c479c36	3
206902	isotretinoin 40 MG Oral Capsule [Accutane]	SBD	5b524a51-a16b-496e-b764-11c98c479c36	3
197843	isotretinoin 10 MG Oral Capsule	SCD	5b524a51-a16b-496e-b764-11c98c479c36	3
197844	isotretinoin 20 MG Oral Capsule	SCD	5b524a51-a16b-496e-b764-11c98c479c36	3
403930	isotretinoin 30 MG Oral Capsule	SCD	5b524a51-a16b-496e-b764-11c98c479c36	3
197845	isotretinoin 40 MG Oral Capsule	SCD	5b524a51-a16b-496e-b764-11c98c479c36	3
206880	Accutane 10 MG Oral Capsule	SY	5b524a51-a16b-496e-b764-11c98c479c36	3
206883	Accutane 20 MG Oral Capsule	SY	5b524a51-a16b-496e-b764-11c98c479c36	3
2473107	Accutane 30 MG Oral Capsule	SY	5b524a51-a16b-496e-b764-11c98c479c36	3
206902	Accutane 40 MG Oral Capsule	SY	5b524a51-a16b-496e-b764-11c98c479c36	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72143-252-30	72143025230	3 BLISTER PACK in 1 CARTON (72143-252-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK	3 blister pack	2022-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isotretinoin Capsules USP	JG Pharma Inc. \| Dr. Reddy's Laboratories Limited FTO-SEZ-Process Unit-02 \| Reed-Lane Inc.	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	3