Prescription drug · NDA
Pentasa (Mesalamine) NDC 54092-191
Mesalamine 500 mg/1 · Capsule · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54092-191-12 | 5409201911254092019112 | 120 CAPSULE in 1 BOTTLE (54092-191-12)Marketed from Jul 8, 2004 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Pentasa
- Generic name (nonproprietary)
- mesalamine
- Active ingredients
- Mesalamine — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 54092
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020049
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 54092-191_42661699-8fcc-40da-a05d-91906f9973e8SPL ID 42661699-8fcc-40da-a05d-91906f9973e8SPL set ID e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606RxCUI 206791, 314092, 476362, 580286UNII 4Q81I59GXCUPC 0354092191123, 0354092189816
- Pharmacologic class
- Aminosalicylate
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454092019112followed by a unit qualifier and the quantityPackage 54092-0191-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
PENTASA is indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients. PENTASA is an aminosalicylate indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 54092-191
- What is NDC 54092-191?
- 54092-191 is the product NDC for Pentasa (mesalamine), Mesalamine 500 mg/1 capsule, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pentasa (Mesalamine).
- What is the active ingredient?
- Mesalamine.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 54092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pentasa?
- 1 other product NDC are listed under this name. See all Pentasa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pentasa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pentasamesalamine | Mesalamine 250 mg/1 | CapsuleOral | Takeda Pharmaceuticals America, Inc. | 54092-189 | 54092-0189-81 |
Other NDCs under NDA 020049
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pentasamesalamine | Mesalamine 250 mg/1 | CapsuleOral | Takeda Pharmaceuticals America, Inc. | 54092-189 |