Pentasa
- Product NDC
- 54092-191
- 11-digit product format
- 540920191
- Labeler code
- 54092
- Product ID
- 54092-191_42661699-8fcc-40da-a05d-91906f9973e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mesalamine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA020049
- Marketing category
- NDA
- Marketing start
- 2004-07-08
- Substance
- MESALAMINE
- Active strength
- 500 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
- Pentasa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MESALAMINE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Q81I59GXC |
| Rxcui | 206791, 314092, 476362, 580286 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54092-191-12 | Pentasa | 120 in 1 BOTTLE | CAPSULE | 120 | | 42 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54092-191 | PENTASA (MESALAMINE) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 42 | Current NDC, Legacy NDC, 1 package rows | 20250117_e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606.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 |
|---|
| 54092-191-12 | 54092019112 | 120 CAPSULE in 1 BOTTLE (54092-191-12) | 120 capsule | 2004-07-08 | 0000-00-00 | No | No | Current |