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 4 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine SulfateHYOSCYAMINE SULFATEPatrin Pharma, Inc.d7189f97-d570-4662-8f1d-cf1da02f01ec2024-09-03Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine sulfateHYOSCYAMINE SULFATEChartwell RX, LLC342edf8e-cca5-4018-9373-0b2e62bc9f4b2024-06-07Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
HyosyneHYOSCYAMINE SULFATELannett Company, Inc.a0e8f7d7-9316-4b78-acc8-17519b9b31652024-04-09Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
HyosyneHYOSCYAMINE SULFATELannett Company, Inc.38f12473-08e0-4970-a6ef-a825cc7de8d82024-04-09Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
Hyoscyamine SulfateHYOSCYAMINE SULFATEBryant Ranch Prepack44119cad-489b-4866-b150-8fbc47f516f62023-08-31Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEBryant Ranch Prepack7258faac-4e08-469b-950c-abe5a5f944452023-08-31Warnings, Adverse reactionsExact identifier
rxcui: 1047905
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEBryant Ranch Prepackdb2dc70e-b2ae-4d65-9c2d-ed4bdfb3c0e72023-08-28Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Hyoscyamine ERHYOSCYAMINE SULFATEMylan Pharmaceuticals Inc.5bbce8c0-a9c9-45b9-8457-1542bd3d94492023-07-15Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEBryant Ranch Prepack57b26b7f-f22d-4ffb-a748-d430572f92a72023-04-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine HydrobromidePHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEIngenus Pharmaceuticals, LLC33bf2df5-bc53-4d57-a9e7-41f3fc0a03f02023-01-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine HydrobromidePHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE HYDROBROMIDEIngenus Pharmaceuticals, LLC0dd71f55-e009-48dd-809d-5f651f7521de2023-01-10Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEVistaPharm, LLC11a48ba9-576b-4e8c-9536-6e83636d69302022-07-07Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84

Reported adverse events (FAERS/openFDA)#

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