Mesalamine
- Product NDC
- 31722-005
- 11-digit product format
- 317220005
- Labeler code
- 31722
- Product ID
- 31722-005_1248c2d3-b241-5551-e063-6294a90a2f4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA213377
- Marketing category
- ANDA
- Marketing start
- 2020-03-19
- 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 |
|---|
| 31722-005-30 | Mesalamine | 5 in 1 CARTON | SUPPOSITORY | 5 | | 4 |
| 31722-005-31 | Mesalamine | 7 in 1 CARTON | SUPPOSITORY | 7 | | 4 |
| 31722-005-32 | Mesalamine | 6 in 1 PACKAGE | SUPPOSITORY | 6 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-005 | MESALAMINE (MESALAMINE) SUPPOSITORY [CAMBER PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240228_efa9d039-ae1f-4cd6-98f2-e87a901dfaeb.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 |
|---|
| 31722-005-30 | 31722000530 | 5 PACKAGE in 1 CARTON (31722-005-30) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32) | 5 package | 2020-03-19 | 0000-00-00 | No | No | Current |
| 31722-005-31 | 31722000531 | 7 PACKAGE in 1 CARTON (31722-005-31) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32) | 7 package | 2020-03-19 | 0000-00-00 | No | No | Current |
| 31722-005-32 | 31722000532 | 6 in 1 PACKAGE | | | | | | Historical |