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 | Type |
|---|---|---|---|
| Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg Rx only | Mylan Pharmaceuticals Inc. | 2023-07-15 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51525-0115-1 | HyoscyamineER | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51525-0115 | HYOSCYAMINE ER (HYOSCYAMINE SULFATE) TABLET, EXTENDED RELEASE [WALLACE PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20181219_5bbce8c0-a9c9-45b9-8457-1542bd3d9449.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51525-0115-1 | EA - Each | 51525-0115 | 85cd83a7-0a00-424b-8c00-f285e52ec8aa | 1 | 2016-07-19 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hyoscyamine Sulfate SL | HYOSCYAMINE SULFATE | Redpharm Drug | 584755e4-fea9-4827-e063-6394a90a4a0a | 2026-08-05 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate | HYOSCYAMINE SULFATE | Granulation Technology, Inc. | 57b12b25-adea-c9bc-e063-6394a90aa925 | 2026-07-29 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate TAB | HYOSCYAMINE SULFATE | REMEDYREPACK INC. | c1c89510-6381-466f-be1a-6b104a335b56 | 2026-06-09 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate SL | HYOSCYAMINE SULFATE | Bryant Ranch Prepack | 3749da41-19f3-46b2-887d-7f8ae2268700 | 2026-06-08 | Warnings, Adverse reactions | F2R8V82B84 |
| Phenohytro | PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDE | ATLANTIC BIOLOGICALS CORP. | a5aaf1db-1938-4073-9da4-c47f959d013e | 2026-05-19 | Warnings, Adverse reactions | F2R8V82B84 |
| Digenyx | HYOSCYAMINE SULFATE 0.125 MG | PureTek Corporation | 512f3202-4ecf-1218-e063-6294a90a0544 | 2026-05-12 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate | HYOSCYAMINE SULFATE | PD-Rx Pharmaceuticals, Inc. | 51a07955-485f-1357-e063-6394a90ad3f8 | 2026-05-11 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate | HYOSCYAMINE SULFATE | Granulation Technology, Inc. | 4f863ae9-d010-b2f5-e063-6394a90a1a95 | 2026-04-15 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate | HYOSCYAMINE SULFATE | Granulation Technology, Inc. | d81bf93e-e73f-4b12-980b-33a5bf453142 | 2026-04-10 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate Sublingual | HYOSCYAMINE SULFATE SUBLINGUAL | Direct_Rx | 4cc2a7a4-b549-b92a-e063-6294a90a51e3 | 2026-03-11 | Warnings, Adverse reactions | F2R8V82B84 |
| UROGESIC BLUE | METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE | EDWARDS PHARMACEUTICALS, INC. | f650dd78-615c-42d3-9b2d-3a989039d80c | 2026-03-05 | Warnings, Adverse reactions | F2R8V82B84 |
| URIBEL TABS | METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE | Mission Pharmacal Company | 09821e01-1135-e75c-e063-6294a90a3451 | 2026-01-08 | Warnings | F2R8V82B84 |
| Hyoscyamine Sulfate | HYOSCYAMINE SULFATE | Northwind Health Company, LLC | da704abd-4e60-f32e-e053-2a95a90a2830 | 2026-01-01 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate TAB | HYOSCYAMINE SULFATE | Northwind Health Company, LLC | f75765ce-262c-e832-e053-6394a90a6066 | 2026-01-01 | Warnings, Adverse reactions | F2R8V82B84 |
| HYOSCYAMINE SULFATE | HYOSCYAMINE SULFATE | BPI Labs LLC | 6c0a1fef-c634-4ecf-9850-d188e6496b90 | 2025-12-26 | Warnings, Adverse reactions | F2R8V82B84 |
| Uretron D/S | METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | ea74f1aa-2b4d-4ccf-e053-2995a90abab5 | 2025-12-18 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate TAB | HYOSCYAMINE SULFATE | QPharma, Inc. | fc7566e6-c043-fcd4-e053-6294a90a77e5 | 2025-12-16 | Warnings, Adverse reactions | F2R8V82B84 |
| Uro-MP | METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS, PHENYL SALICYLATE, METHYLENE BLUE AND HYOSCYAMINE SULFATE | Method Pharmaceuticals, LLC | 1e1b0dee-1a3b-4846-a212-c9febb3fc17d | 2025-10-29 | Warnings, Adverse reactions | F2R8V82B84 |
| OSCIMIN | HYOSCYAMINE SULFATE | Larken Laboratories, Inc. | 8504adad-f6d0-4671-b655-4b62bf29a516 | 2025-10-21 | Warnings, Adverse reactions | F2R8V82B84 |
| Hyoscyamine Sulfate ODT | HYOSCYAMINE SULFATE | Acella Pharmaceuticals, LLC | eef6babc-241f-40b6-b8c8-daa92bbd0a25 | 2025-10-21 | Warnings, Adverse reactions | F2R8V82B84 |