Mesalamine
- Product NDC
- 63629-2397
- 11-digit product format
- 636292397
- Labeler code
- 63629
- Product ID
- 63629-2397_f36797f1-e0b0-43e2-8b3c-67090bbe76e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207448
- Marketing category
- ANDA
- Marketing start
- 2019-06-05
- Substance
- MESALAMINE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- 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
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MESALAMINE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 248420 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 table| 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 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 |
|---|
| 63629-2397-1 | 63629239701 | 5 PACKAGE in 1 CARTON (63629-2397-1) / 6 SUPPOSITORY in 1 PACKAGE | 5 package | 2021-05-04 | 0000-00-00 | No | No | Current |