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 109 of 109 · 2,165 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer Kids Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distribution, Inc.	7415511e-1ecf-4646-b64b-267fbf7d116b	2016-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distributing Inc.	2434de23-bcc9-4a83-9945-16fc3f2b8c61	2016-06-01	Warnings	Exact identifier unii: 15FIX9V2JP
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	6a996e03-907f-4e6a-b232-0892b86956b0	2015-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
Renewal Firming Day Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BURT'S BEES, INC.	18ceb5d8-4b76-6a54-e054-00144ff88e88	2015-06-18	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD.	30468afc-9616-4765-b046-12e97a0a7827	2010-12-20	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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