Mesalamine
- Product NDC
- 0472-1915
- 11-digit product format
- 004721915
- Labeler code
- 0472
- Product ID
- 0472-1915_380df1f0-2282-4c49-bd7c-40b244f875d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA205654
- Marketing category
- ANDA
- Marketing start
- 2021-04-23
- Marketing end
- 2026-11-30
- 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 |
|---|
| 0472-1915-01 | Mesalamine | 1 in 1 POUCH | SUPPOSITORY | 1 | | 9 |
| 0472-1915-30 | Mesalamine | 30 in 1 BOX | SUPPOSITORY | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0472-1915 | MESALAMINE SUPPOSITORY [ACTAVIS PHARMA, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231218_73317da3-cba0-4106-9e88-79b0e2f642af.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 |
|---|
| 0472-1915-01 | 00472191501 | 1 in 1 POUCH | | | | | | Historical |
| 0472-1915-30 | 00472191530 | 30 POUCH in 1 BOX (0472-1915-30) / 1 SUPPOSITORY in 1 POUCH (0472-1915-01) | 30 pouch | 2021-04-23 | 2026-11-30 | No | No | Current |