Isotretinoin

Product NDC: 70771-1663
Requested package NDC: 70771-1663-8
11-digit product format: 707711663
Labeler code: 70771
Product ID: 70771-1663_26618883-d91c-476e-b22c-4d0e204b9dd3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isotretinoin
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA216633
Marketing category: ANDA
Marketing start: 2025-06-09
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 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	Approval date
A216633-001	ISOTRETINOIN	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB2	2025-05-22
A216633-002	ISOTRETINOIN	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB2	2025-05-22
A216633-003	ISOTRETINOIN	ISOTRETINOIN	25MG	CAPSULE / ORAL	AB2	2025-05-22
A216633-004	ISOTRETINOIN	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB2	2025-05-22
A216633-005	ISOTRETINOIN	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2	2025-05-22
A216633-006	ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2	2025-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A216633-001	AB2
A216633-002	AB2
A216633-003	AB2
A216633-004	AB2
A216633-005	AB2
A216633-006	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 2 of 2 · 42 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
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216633-005	ISOTRETINOIN	35MG	CAPSULE / ORAL	AB2		2025-05-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216633-006	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB2		2025-05-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A216633-001	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216633-002	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216633-003	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216633-004	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216633-005	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216633-006	AB2	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A216633-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216633-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216633-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216633-004	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216633-005	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216633-006	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216633-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216633-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216633-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216633-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216633-005	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216633-006	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216633-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216633-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216633-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216633-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216633-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216633-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216633-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216633-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216633-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216633-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216633-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216633-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216633-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216633-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216633-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216633-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216633-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216633-006	AB2	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216633-001	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216633-002	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216633-003	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216633-004	AB2	1	`a50c72e98297…`

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: Isotretinoin
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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
245898e5-3a61-4d6a-8375-8b3a8b7364ac	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
70771-1663-2	Isotretinoin	10 in 1 BLISTER PACK	CAPSULE	10		1
70771-1663-8	Isotretinoin	3 in 1 CARTON	CAPSULE	3		1

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
Isotretinoin	ISOTRETINOIN	Zydus Pharmaceuticals USA Inc.	31f62a49-4c6d-4ce3-a0ca-d159562370b1	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216633 application number: ANDA216633
Isotretinoin	ISOTRETINOIN	Zydus Lifesciences Limited	245898e5-3a61-4d6a-8375-8b3a8b7364ac	2025-06-04		Exact identifier application applno (ANDA): 216633 application number: ANDA216633 ndc (package): 70771-1663-8 ndc (product): 70771-1663 ndc11 (package): 70771166308

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
197843	ISOtretinoin 10 MG Oral Capsule	PSN	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
197844	ISOtretinoin 20 MG Oral Capsule	PSN	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
1547561	ISOtretinoin 25 MG Oral Capsule	PSN	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
403930	ISOtretinoin 30 MG Oral Capsule	PSN	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
1547565	ISOtretinoin 35 MG Oral Capsule	PSN	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
197845	ISOtretinoin 40 MG Oral Capsule	PSN	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
197843	isotretinoin 10 MG Oral Capsule	SCD	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
197844	isotretinoin 20 MG Oral Capsule	SCD	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
1547561	isotretinoin 25 MG Oral Capsule	SCD	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
403930	isotretinoin 30 MG Oral Capsule	SCD	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
1547565	isotretinoin 35 MG Oral Capsule	SCD	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1
197845	isotretinoin 40 MG Oral Capsule	SCD	245898e5-3a61-4d6a-8375-8b3a8b7364ac	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70771-1663-8	70771166308	3 BLISTER PACK in 1 CARTON (70771-1663-8) / 10 CAPSULE in 1 BLISTER PACK (70771-1663-2)	3 blister pack	2025-06-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isotretinoin - Zydus Lifesciences Limited	Zydus Lifesciences Limited	2025-06-04	HUMAN PRESCRIPTION DRUG LABEL	1