Mesalamine
- Product NDC
- 63629-8678
- 11-digit product format
- 636298678
- Labeler code
- 63629
- Product ID
- 63629-8678_6e83a681-f1fa-4b8e-827c-0d3fcf7ade93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- KIT
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076751
- Marketing category
- ANDA
- Marketing start
- 2009-09-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mesalamine
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 238151 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-098-46 | Mesalamine | 60 mL in 1 BOTTLE | ENEMA | 420 mL | 4 g in 60mL | 106 |
| 63629-8678-1 | Mesalamine | 1 in 1 CARTON | KIT | 1 | | 106 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8678 | MESALAMINE KIT [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC, 2 package rows | 20241109_9756d07b-2939-460f-94d3-e338c28cb993.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45802-098-46 | 45802009846 | 60 mL in 1 BOTTLE | 60 ml | | | | | Historical |
| 63629-8678-1 | 63629867801 | 1 KIT in 1 CARTON (63629-8678-1) * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET | 1 kit | 2009-09-01 | 0000-00-00 | No | No | Current |