Mesalamine
- Product NDC
- 70771-1513
- 11-digit product format
- 707711513
- Labeler code
- 70771
- Product ID
- 70771-1513_923f1e77-becd-45e6-a9e8-12cd5942c828
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA208953
- Marketing category
- ANDA
- Marketing start
- 2020-02-14
- 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 |
|---|
| 70771-1513-6 | Mesalamine | 6 in 1 BLISTER PACK | SUPPOSITORY | 6 | | 7 |
| 70771-1513-7 | Mesalamine | 5 in 1 POUCH | SUPPOSITORY | 5 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1513 | MESALAMINE SUPPOSITORY [ZYDUS LIFESCIENCES LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250110_aa63b4bb-2de7-40aa-b26b-1b00b0183eac.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 |
|---|
| 70771-1513-6 | 70771151306 | 6 in 1 BLISTER PACK | | | | | | Historical |
| 70771-1513-7 | 70771151307 | 5 BLISTER PACK in 1 POUCH (70771-1513-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70771-1513-6) | 5 blister pack | 2020-02-14 | 0000-00-00 | No | No | Current |