Mesalamine
- Product NDC
- 16571-246
- 11-digit product format
- 165710246
- Labeler code
- 16571
- Product ID
- 16571-246_92e26463-9c71-456e-b800-351162846b68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesalamine
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA219028
- Marketing category
- ANDA
- Marketing start
- 2025-04-14
- 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 |
|---|
| 16571-246-03 | Mesalamine | 5 in 1 CARTON | SUPPOSITORY | 5 | | 2 |
| 16571-246-16 | Mesalamine | 6 in 1 BLISTER PACK | SUPPOSITORY | 6 | | 2 |
| 16571-246-72 | Mesalamine | 12 in 1 CARTON | SUPPOSITORY | 12 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-246 | MESALAMINE SUPPOSITORY [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 3 package rows | 20250418_c26ae6cb-041b-4cfc-90ca-c4e1cb23458c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-246-03 | 16571024603 | 5 BLISTER PACK in 1 CARTON (16571-246-03) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16) | 5 blister pack | 2025-04-14 | No | No | Current |
| 16571-246-16 | 16571024616 | 6 in 1 BLISTER PACK | | | | | Historical |
| 16571-246-72 | 16571024672 | 12 BLISTER PACK in 1 CARTON (16571-246-72) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16) | 12 blister pack | 2025-04-14 | No | No | Current |