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 3 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevbidHYOSCYAMINE SULFATEViatris Specialty LLCeb13c96f-319a-46f4-9955-ef5fa0a5f1102025-07-15Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
NuLevHYOSCYAMINE SULFATEViatris Specialty LLCae2a78b2-b811-11e2-9e96-0800200c9a662025-07-15Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine Sulfate TABHYOSCYAMINE SULFATEBryant Ranch Prepackb8759036-81f9-4e31-8763-9e42cf78d9c52025-06-02Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEProficient Rx LP1f4b1ed7-bbba-4b2c-8139-b35cb428587d2025-06-01Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
HyosyneHYOSCYAMINE SULFATEATLANTIC BIOLOGICALS CORP.08ee0b24-a05b-451c-9d29-975570baed482025-05-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
HyosyneHYOSCYAMINE SULFATEATLANTIC BIOLOGICALS CORP.d022cde6-90c7-48b5-8022-cf7b76f4da192025-05-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine Sulfate SLHYOSCYAMINE SULFATEWestminster Pharmaceuticals, LLC2b7d1604-3e95-4fc9-a65d-2c06ace160092025-04-21Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEWestminster Pharmaceuticals, LLC9c0ae67b-7887-4820-ad77-8ea7261f9ed32025-04-21Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
Hyoscyamine Sulfate ODTHYOSCYAMINE SULFATEWestminster Pharmaceuticals, LLC9429898d-301f-4ebc-8b1d-60595f76f1e32025-04-09Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
MB CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLC2efeb281-b84b-4750-e063-6394a90a27ee2025-02-25Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
URIMAR-T CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLCcf7c3d65-11d2-49cd-b207-8ccc6a221fe02025-01-08Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.c93cccdc-2f92-4cb3-9d14-06acdd51d94c2024-12-05Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.4dba30db-7979-455f-a225-24f0a04d744e2024-12-05Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATENCS HealthCare of KY, LLC dba Vangard Labsfdf1f194-2e18-403c-be28-7dd58739ead72024-11-13Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATENCS HealthCare of KY, LLC dba Vangard Labse291da2e-a693-43f5-8cdd-2b8725371b792024-09-30Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEChartwell RX, LLC526399a7-03ea-4d09-8dcd-d5cb012ab5c52024-09-25Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEPatrin Pharma, Inc.84be0ac5-f56f-4a06-a923-ca25252c5fef2024-09-04Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEPatrin Pharma, Inc.cd79f902-2a7b-4f3f-ac17-beaa254adfbc2024-09-04Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEPatrin Pharma, Inc.56910c34-cf78-4dcd-a594-6efec255e6952024-09-03Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84

Reported adverse events (FAERS/openFDA)#

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