FDA.reportPublic FDA data

NDC 51525-0115-01 - Hyoscyamine ER

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
51525-0115
Requested NDC
51525-0115-01
Package NDCs from labels
51525-0115-1, 51525-0115-01
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2023-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg Rx onlyMylan Pharmaceuticals Inc.2023-07-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51525-0115-1HyoscyamineER100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51525-0115HYOSCYAMINE ER (HYOSCYAMINE SULFATE) TABLET, EXTENDED RELEASE [WALLACE PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20181219_5bbce8c0-a9c9-45b9-8457-1542bd3d9449.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51525-0115-1EA - Each51525-011585cd83a7-0a00-424b-8c00-f285e52ec8aa12016-07-19

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 4 · 64 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.3859133e-88bd-4dd5-90a0-82b64347f1db2025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 1046770
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
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.66fdfc33-a7b9-465b-84f1-012cdf5517fd2025-09-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
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
unii: F2R8V82B84
LevbidHYOSCYAMINE SULFATEViatris Specialty LLCeb13c96f-319a-46f4-9955-ef5fa0a5f1102025-07-15Warnings, Adverse reactionsExact identifier
rxcui: 1046770
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
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEProficient Rx LP1f4b1ed7-bbba-4b2c-8139-b35cb428587d2025-06-01Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
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
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

Reported adverse events (FAERS/openFDA)#

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