NDC 70518-3847-01 - Hyoscyamine Sulfate TAB

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: 70518-3847
Requested NDC: 70518-3847-01
Package NDCs from labels: 70518-3847-0, 70518-3847-1, 70518-3847-01
Manufacturer: REMEDYREPACK INC.
Effective date: 2026-06-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Hyoscyamine Sulfate Tab Oral Tablets Rx Only	REMEDYREPACK INC.	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-3847-0	Hyoscyamine Sulfate TAB	90 in 1 BOTTLE, PLASTIC	TABLET	90		7
70518-3847-1	Hyoscyamine Sulfate TAB	180 in 1 BOTTLE, PLASTIC	TABLET	180		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3847	HYOSCYAMINE SULFATE TAB (HYOSCYAMINE SULFATE) TABLET [REMEDYREPACK INC.]	6	Current NDC, 2 package rows	20241206_c1c89510-6381-466f-be1a-6b104a335b56.zip

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 5 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenohytro	PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE	Winder Laboratories, LLC	27c8baac-f8ce-46d8-8a0f-ff769dd408d9	2019-12-27	Warnings, Adverse reactions	Exact identifier unii: F2R8V82B84
Phenohytro	PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDE	Winder Laboratories LLC	29be31ef-108e-4b45-9ecc-b6d671da2826	2019-10-04	Warnings, Adverse reactions	Exact identifier unii: F2R8V82B84
URELLE	HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	Viatris Specialty LLC	1d80a11c-6f86-403b-85d4-32ec1924dbe9	2015-01-13	Warnings, Adverse reactions	Exact identifier unii: F2R8V82B84
Levsin SL	HYOSCYAMINE SULFATE	Viatris Specialty LLC	f38ece41-b890-11e2-9e96-0800200c9a66	2013-05-14	Warnings, Adverse reactions	Exact identifier unii: F2R8V82B84

Reported adverse events (FAERS/openFDA)#

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