Mesalamine
- Product NDC
- 64980-282
- 11-digit product format
- 649800282
- Labeler code
- 64980
- Product ID
- 64980-282_18f268ab-16e6-4456-8e7d-42b30ccf82af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA207448
- Marketing category
- ANDA
- Marketing start
- 2019-06-05
- Marketing end
- 2026-10-31
- Substance
- MESALAMINE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mesalamine
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 |
|---|
| 64980-282-03 | Mesalamine | 6 in 1 PACKAGE | SUPPOSITORY | 6 | | 11 |
| 64980-282-03 | Mesalamine | 5 in 1 CARTON | SUPPOSITORY | 5 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-282 | MESALAMINE SUPPOSITORY [RISING PHARMA HOLDINGS, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241018_de981df1-747a-480d-a866-e72332a1544d.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 |
|---|
| 64980-282-03 | 64980028203 | 5 PACKAGE in 1 CARTON (64980-282-03) / 6 SUPPOSITORY in 1 PACKAGE | 5 package | 2019-06-05 | 2026-10-31 | No | No | Current |