NDC 16714-245-01 - Mesalamine
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
- 16714-245
- Requested NDC
- 16714-245-01
- Package NDCs from labels
- 16714-245-01, 16714-245-30
- Manufacturer
- Northstar Rx LLC. | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
- Effective date
- 2025-01-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Mesalamine - Northstar Rx LLC. | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | Northstar Rx LLC. | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-01-10 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16714-245-01 | Mesalamine | 6 in 1 BLISTER PACK | SUPPOSITORY | 6 | 5 | |
| 16714-245-30 | Mesalamine | 5 in 1 POUCH | SUPPOSITORY | 5 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-245-01 | EA - Each | 16714-245 | 54fa7f3f-98d9-44e2-ad10-b8dde0f3fb13 | 1 | 2021-11-09 |
| 16714-245-30 | EA - Each | 16714-245 | 7c256c1f-e956-4c98-a065-0e0517aca2c2 | 1 | 2021-11-09 |
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 |
|---|---|---|---|---|---|---|
| Pentasa | MESALAMINE | Takeda Pharmaceuticals America, Inc. | e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606 | 2025-01-15 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Northstar Rx LLC. | 7ac78fa0-60a8-48dd-abc4-a487f98039a2 | 2025-01-10 | Warnings, Adverse reactions | ANDA208953 16714-245-01 16714-245-30 16714-245 16714024501 248420 d5210f4f-1604-4319-ad99-b44167e66c00 7ac78fa0-60a8-48dd-abc4-a487f98039a2 4Q81I59GXC |
| Mesalamine | MESALAMINE | Takeda Pharmaceuticals America, Inc. | 4e3b6325-a5bf-4c47-931c-142c0e4d7c3a | 2025-01-09 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | AvPAK | f2657911-6f06-71fb-e053-2a95a90ae6f7 | 2025-01-09 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Zydus Lifesciences Limited | aa63b4bb-2de7-40aa-b26b-1b00b0183eac | 2025-01-09 | ANDA208953 248420 4Q81I59GXC | |
| Mesalamine | MESALAMINE | Zydus Pharmaceuticals USA Inc. | f458d574-7b5b-44f1-86be-8b18880dc67f | 2025-01-08 | Warnings, Adverse reactions | ANDA208953 248420 4Q81I59GXC |
| Bliss GVS Hemorrhoidal | HARD FAT, PHENYLEPHRINE HCL | Bliss GVS Pharma Limited | 88c49f6c-2a48-2dae-e053-2a95a90af20a | 2024-12-19 | Warnings | 8334LX7S21 |
| mesalamine | MESALAMINE | Zydus Lifesciences Limited | 29c0dd58-d2cf-40fa-bc32-0eab61937331 | 2024-11-30 | 4Q81I59GXC | |
| mesalamine | MESALAMINE | Zydus Lifesciences Limited | 52d96501-47f3-45d8-a181-98763b9f8965 | 2024-11-30 | 4Q81I59GXC | |
| Mesalamine | MESALAMINE | Zydus Lifesciences Limited | 04073681-a834-4f45-91c5-224b608b30e6 | 2024-11-30 | 4Q81I59GXC | |
| Mesalamine | MESALAMINE | American Health Packaging | 77140634-9f32-40ca-8c83-9fcc3e373c16 | 2024-11-22 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | NorthStar RxLLC | 8233f158-9da5-4fd2-b2c3-9db89448371f | 2024-11-21 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | American Health Packaging | a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb | 2024-11-21 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Bryant Ranch Prepack | b48df65a-a717-479e-9122-8b0f1406c841 | 2024-11-01 | Warnings, Adverse reactions | 248420 4Q81I59GXC |
| Canasa | MESALAMINE | Allergan, Inc. | 89d91601-152b-4398-bebe-af1c023e9935 | 2024-09-08 | Warnings, Adverse reactions | 248420 4Q81I59GXC |
| Mesalamine | MESALAMINE | Sun Pharmaceutical Industries Inc. | c2f84490-70b8-4998-907d-a77e9f791de1 | 2024-08-27 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Bryant Ranch Prepack | baa76dde-3c5b-4ff4-ba0c-f19660a796c1 | 2024-08-14 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Padagis Israel Pharmaceuticals Ltd | a4ddf68d-1502-4242-89aa-c96436bdcbf6 | 2024-08-01 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Ascend Laboratories, LLC | 43f69db3-81ac-4da4-a61f-fbba6299d9c2 | 2024-07-03 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Teva Pharmaceuticals, Inc. | e3b84397-a5a5-40cf-8145-0584103d465f | 2024-06-28 | Warnings, Adverse reactions | 4Q81I59GXC |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.