NDC 68084-040-11 - Misoprostol

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: 68084-040
Requested NDC: 68084-040-11
Package NDCs from labels: 68084-040-11, 68084-040-01
Manufacturer: American Health Packaging
Effective date: 2023-04-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Misoprostol - American Health Packaging	American Health Packaging	2023-04-12	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-040-01	EA - Each	68084-040	67d629e4-fb1e-4668-ad00-6080b7f2073b	1	2013-08-02
68084-040-11	EA - Each	68084-040	3404c5d8-e053-4d73-8cc8-07c3b352496b	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MISOPROSTOL	ACTIVE INGREDIENT	0E43V0BB57	MISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]	1
MISOPROSTOL	ACTIVE MOIETY	0E43V0BB57	MISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	MISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	MISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING]	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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Proficient Rx LP	33f7db0b-f049-4d2e-abf5-4db97222e175	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 0E43V0BB57
Misoprostol	MISOPROSTOL	Lupin Pharmaceuticals,Inc.	14f73ae3-7d8d-4d10-b668-8bd5adf8032c	2020-12-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA091667 ndc (product): 43386-160 ndc (product): 43386-161 rxcui: 311727 rxcui: 317128 spl id: b702aa1b-6c21-e44f-e053-2995a90a16f2 spl set id: 14f73ae3-7d8d-4d10-b668-8bd5adf8032c unii: 0E43V0BB57
Misoprostol	MISOPROSTOL	Novel Laboratories, Inc.	a46d05a2-5014-40ff-8f1b-9eca1b0aff3a	2020-12-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA091667 rxcui: 311727 rxcui: 317128 unii: 0E43V0BB57

Reported adverse events (FAERS/openFDA)#

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