NDC 63629-2397-01 - 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
- 63629-2397
- Requested NDC
- 63629-2397-01
- Package NDCs from labels
- 63629-2397-1, 63629-2397-01
- Manufacturer
- Bryant Ranch Prepack
- Effective date
- 2024-06-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Mesalamine - Bryant Ranch Prepack | Bryant Ranch Prepack | 2024-06-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-2397-1 | Mesalamine | 5 in 1 CARTON | SUPPOSITORY | 5 | 103 | |
| 63629-2397-1 | Mesalamine | 6 in 1 PACKAGE | SUPPOSITORY | 6 | 103 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-2397 | MESALAMINE SUPPOSITORY [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 2 package rows | 20240629_06792d20-d7e9-4b66-a4cb-cd0cf1a2db25.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2397-1 | EA - Each | 63629-2397 | fe8dea23-de24-4c10-8fd7-d6c94c6ef06a | 1 | 2021-06-02 |
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 |
|---|---|---|---|---|---|---|
| Mesalamine | MESALAMINE | Bryant Ranch Prepack | 06792d20-d7e9-4b66-a4cb-cd0cf1a2db25 | 2024-06-28 | Warnings, Adverse reactions | ANDA207448 63629-2397-1 63629-2397 63629239701 248420 f36797f1-e0b0-43e2-8b3c-67090bbe76e8 06792d20-d7e9-4b66-a4cb-cd0cf1a2db25 4Q81I59GXC |
| Mesalamine | MESALAMINE | Rising Pharma Holdings, Inc. | de981df1-747a-480d-a866-e72332a1544d | 2024-06-14 | Warnings, Adverse reactions | ANDA207448 64980-282 248420 18f268ab-16e6-4456-8e7d-42b30ccf82af de981df1-747a-480d-a866-e72332a1544d 4Q81I59GXC |
| MESALAMINE | MESALAMINE | Bryant Ranch Prepack | 063ca661-1b5c-4941-a5b9-5dd0fa46b3d0 | 2024-05-29 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Amneal Pharmaceuticals LLC | 00f77203-3615-47e8-ae25-6e1cf8a2a00a | 2024-05-23 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Bryant Ranch Prepack | c9b1ef9d-1d06-48e7-87d2-7985b99124a6 | 2024-05-01 | Warnings, Adverse reactions | 4Q81I59GXC |
| mesalamine | MESALAMINE | Golden State Medical Supply, Inc. | 170657d1-1f32-f036-e063-6294a90a4ed4 | 2024-04-26 | Warnings, Adverse reactions | 4Q81I59GXC |
| MESALAMINE | MESALAMINE | Lannett Company Inc. | 29dbe417-15a9-4c4d-846b-81cabda7ac70 | 2024-02-29 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Camber Pharmaceuticals, Inc. | efa9d039-ae1f-4cd6-98f2-e87a901dfaeb | 2024-02-26 | Warnings, Adverse reactions | 248420 4Q81I59GXC |
| Mesalamine | MESALAMINE | Camber Pharmaceuticals, Inc. | 04ce2182-2e8c-4598-a269-550cfaddde6c | 2024-02-15 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | ANI Pharmaceuticals, Inc. | 3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac | 2024-02-14 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Aurobindo Pharma Limited | d6c0fc76-644e-4301-9672-f432061e3d37 | 2024-01-20 | Warnings, Adverse reactions | 4Q81I59GXC |
| MESALAMINE | MESALAMINE | Alembic Pharmaceuticals Inc. | 87d3d62d-2dc3-4e6f-be33-cabbca12e8f7 | 2024-01-09 | Warnings, Adverse reactions | 4Q81I59GXC |
| mesalamine | MESALAMINE | Teva Pharmaceuticals USA, Inc. | 8d27a608-3ba1-4799-be38-c00fb08ce3ce | 2023-12-19 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine Rectal | MESALAMINE | Amring Pharmaceuticals Inc. | 87de237c-febb-42ca-b2a4-b444396f8640 | 2023-12-15 | Warnings, Adverse reactions | 248420 4Q81I59GXC |
| Mesalamine | MESALAMINE | Sun Pharmaceutical Industries, Inc. | fd8b02de-7dfa-444d-a1f8-1436b578e0cb | 2023-12-01 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Mylan Pharmaceuticals Inc. | c8b93ea3-0367-4605-b87f-06c3812ff3b7 | 2023-11-30 | Warnings, Adverse reactions | 4Q81I59GXC |
| Mesalamine | MESALAMINE | Zydus Pharmaceuticals USA Inc. | cd8493f7-91fd-4c2d-b3d7-c1301825586b | 2023-10-26 | Warnings, Adverse reactions | 4Q81I59GXC |
| mesalamine | MESALAMINE | Zydus Pharmaceuticals USA Inc. | 533bfaf5-0add-4b49-a4f2-ddea2b83f65d | 2023-10-26 | Warnings, Adverse reactions | 4Q81I59GXC |
| MESALAMINE | MESALAMINE | Alembic Pharmaceuticals Limited | 4ef59b85-e5a5-479f-a1fe-e1cee4d87670 | 2022-11-07 | Warnings, Adverse reactions | 4Q81I59GXC |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.