NDC 70710-1641-01 - Lubiprostone

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: 70710-1641
Requested NDC: 70710-1641-01
Package NDCs from labels: 70710-1641-6, 70710-1641-1, 70710-1641-01
Manufacturer: Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date: 2025-02-06
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Lubiprostone - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-06	HUMAN PRESCRIPTION DRUG LABEL
Lubiprostone - Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-03-27	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-1641-1	Lubiprostone	100 in 1 BOTTLE	CAPSULE	100		1
70710-1641-6	Lubiprostone	60 in 1 BOTTLE	CAPSULE	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1641	LUBIPROSTONE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]	1	Current NDC, 2 package rows	20230328_6c11a204-6831-4269-a3c4-1702ed83f74b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-1641-6	EA - Each	70710-1641	79a1fbe8-ccab-408f-a0af-228071c2b415	1	2023-12-05

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 118 of 118 · 2,344 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
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.