FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Hyoscyamine Sulfate Tab Oral Tablets Rx OnlyREMEDYREPACK INC.2026-06-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3847-0Hyoscyamine Sulfate TAB90 in 1 BOTTLE, PLASTICTABLET907
70518-3847-1Hyoscyamine Sulfate TAB180 in 1 BOTTLE, PLASTICTABLET1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3847HYOSCYAMINE SULFATE TAB (HYOSCYAMINE SULFATE) TABLET [REMEDYREPACK INC.]6Current NDC, 2 package rows20241206_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 2 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine Sulfate TABHYOSCYAMINE SULFATEQPharma, Inc.fc7566e6-c043-fcd4-e053-6294a90a77e52025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Uro-MPMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS, PHENYL SALICYLATE, METHYLENE BLUE AND HYOSCYAMINE SULFATEMethod Pharmaceuticals, LLC1e1b0dee-1a3b-4846-a212-c9febb3fc17d2025-10-29Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OSCIMINHYOSCYAMINE SULFATELarken Laboratories, Inc.8504adad-f6d0-4671-b655-4b62bf29a5162025-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
Hyoscyamine Sulfate ODTHYOSCYAMINE SULFATEAcella Pharmaceuticals, LLCeef6babc-241f-40b6-b8c8-daa92bbd0a252025-10-21Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATELaser Pharmaceuticals, LLCb12f856f-7157-4aee-bf73-1fdcb4834ffc2025-10-17Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
OSCIMINHYOSCYAMINE SULFATELarken Laboratories, Inc.2d5fa637-0696-40fe-9bc1-fcb6f07a50f62025-10-16Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine Sulfate SLHYOSCYAMINE SULFATEAcella Pharmaceuticals, LLC8aab1dce-0699-4866-8707-33b4e2177bdd2025-10-02Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine Sulfate TABHYOSCYAMINE SULFATEAcella Pharmaceuticals, LLC49fe1783-ab0c-4adb-869b-384121cf7f052025-10-02Warnings, Adverse reactionsExact identifier
ndc (product): 42192-340
rxcui: 1047905
spl id: 40334131-5c80-1b60-e063-6394a90ae21f
spl set id: 49fe1783-ab0c-4adb-869b-384121cf7f05
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.3859133e-88bd-4dd5-90a0-82b64347f1db2025-09-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.48fa3d71-8c78-4f29-b1f0-ecac8c36473e2025-09-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.cdb8f10a-b426-448f-8991-7724ffa88cb52025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.66fdfc33-a7b9-465b-84f1-012cdf5517fd2025-09-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.d820e42d-ad2b-4e11-907b-a94d698ca2852025-08-13Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
LevsinHYOSCYAMINE SULFATEViatris Specialty LLC32388e18-08de-455c-aad4-9c2264435f0f2025-07-15Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84

Reported adverse events (FAERS/openFDA)#

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