NDC 57664-024-98 - Isotretinoin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 57664-024
Requested NDC: 57664-024-98
Package NDCs from labels: 57664-024-98, 57664-024-97
Manufacturer: Sun Pharmaceutical Industries, Inc. | Galephar Pharmaceutical Research Inc.
Effective date: 2024-01-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Isotretinoin	Sun Pharmaceutical Industries, Inc. \| Galephar Pharmaceutical Research Inc.	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57664-024-97	Isotretinoin	3 in 1 BOX	CAPSULE	3		2
57664-024-98	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
57664-024	ISOTRETINOIN CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240110_b44200ba-6672-4ea7-b151-7caec3f53c9c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-024-97	EA - Each	57664-024	3dba35f3-b1c6-4e71-a531-0b2b42912ee8	1	2021-05-05
57664-024-98	EA - Each	57664-024	7c30c008-9e3b-48a2-be93-cf814b6a5ae2	1	2021-05-05

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 107 of 109 · 2,165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Bronze	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	199dde64-1dd3-4eb6-baef-261c97162f79	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Creme	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	753c34f2-3cb8-4df7-9aeb-ea926fb0279a	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Dune	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	745dd675-86ee-4acc-8333-4870e0a57c75	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	e66734e4-34e7-4674-bb98-bdca931a176d	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	bf78f7a7-93ca-425e-8571-175da6798e8e	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	418cdd4a-23f7-4181-b734-5ab7456494a2	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	50138c51-f424-4b07-b3eb-c0d31d8ecf16	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	01a861b9-0ab6-4c4c-a407-428a64509a1c	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d5431d62-fded-4cdc-81a1-5b5e3eb92873	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	52c3378f-6b99-42fa-900e-8a693864c615	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Vanilla	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d701c221-9f68-47ff-b766-2f4f1998649f	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Amber	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	7f5e6872-4d26-410e-8afe-16a016f9a399	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm Ivory	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	1124ba7d-a328-409b-8c88-e74bb3e501f5	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	9c407dc7-fcde-4660-9a06-57bd8a6b867d	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Chestnut	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	f07e8bb2-30ae-4337-ad60-84f55f2ff354	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
Intralipid	I.V. FAT EMULSION	Baxter Healthcare Corporation	cbd3396e-6b85-41bf-82d2-940beba86686	2019-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 241ATL177A
CLE CCC Golden Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	b7a4847f-b84d-4f36-8787-104eccd838a0	2018-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	229c20a3-6288-4ac3-9098-6d1622e906ab	2018-11-29	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	fc90fb8a-44b3-47cd-882e-94ed324ed389	2018-11-27	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	b585f216-4234-47c5-9a6b-8b133ef48aae	2018-11-27	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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