Rowasa
- Product NDC
- 0037-0066
- 11-digit product format
- 000370066
- Labeler code
- 0037
- Product ID
- 0037-0066_b6652e84-f693-4388-bd29-21e035ffe4a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- SUSPENSION
- Route
- RECTAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA019618
- Marketing category
- NDA
- Marketing start
- 2016-03-24
- Substance
- MESALAMINE
- Active strength
- 4 g/60mL
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rowasa
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MESALAMINE | 4 g/60mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 206798, 238151 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0037-0066-03 | Rowasa | 28 in 1 CARTON | SUSPENSION | 28 | | 17 |
| 0037-0066-05 | Rowasa | 7 in 1 CARTON | SUSPENSION | 7 | | 17 |
| 0037-0066-06 | Rowasa | 60 mL in 1 BOTTLE, DISPENSING | SUSPENSION | 60 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0037-0066 | ROWASA (MESALAMINE) SUSPENSION [MEDA PHARMACEUTICALS INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20241004_e505ab99-1943-4216-a178-4d5dbe64e3b2.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 |
|---|
| 0037-0066-03 | 00037006603 | 28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06) | | 2016-03-24 | 0000-00-00 | No | No | Current |
| 0037-0066-05 | 00037006605 | 7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06) | | 2016-03-24 | 2027-07-31 | No | No | Current |
| 0037-0066-06 | 00037006606 | 60 mL in 1 BOTTLE, DISPENSING | 60 ml | | | | | Historical |