Mesalamine
- Product NDC
- 0480-7750
- 11-digit product format
- 004807750
- Labeler code
- 0480
- Product ID
- 0480-7750_dcee5545-97f3-4418-87f6-5060e540342d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA213191
- Marketing category
- ANDA
- Marketing start
- 2024-08-22
- Substance
- MESALAMINE
- Active strength
- 800 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 833234 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-7750-80 | Mesalamine | 180 in 1 BOTTLE | TABLET, DELAYED RELEASE | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-7750 | MESALAMINE TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240824_e3b84397-a5a5-40cf-8145-0584103d465f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-7750-80 | 00480775080 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-7750-80) | 2024-08-22 | No | No | Current |