Prescription drug · ANDA
mesalamine NDC 0904-6832
Mesalamine 1.2 g/1 · Tablet, Delayed release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6832-04 | 0090468320400904683204 | 30 BLISTER PACK in 1 CARTON (0904-6832-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jun 19, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- mesalamine
- Generic name (nonproprietary)
- mesalamine
- Active ingredients
- Mesalamine — 1.2 g/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091640
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 0904-6832_e7f5f41b-7561-46f4-b971-302257bc0178SPL ID e7f5f41b-7561-46f4-b971-302257bc0178SPL set ID 14ac4435-903b-41f5-a3c4-8c73de3e4cefRxCUI 686429UNII 4Q81I59GXC
- 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
N400904683204followed by a unit qualifier and the quantityPackage 00904-6832-04. 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)
Mesalamine delayed-release tablets are indicated for the: • induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. • treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Mesalamine delayed-release tablets are an aminosalicylate indicated for the: • induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 ) • treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0904-6832
- What is NDC 0904-6832?
- 0904-6832 is the product NDC for mesalamine, Mesalamine 1.2 g/1 tablet, delayed release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- mesalamine.
- What is the active ingredient?
- Mesalamine.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for mesalamine?
- 58 other product NDCs are listed under this name. See all mesalamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other mesalamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mesalamine | Mesalamine 4 g/60mL | SuspensionRectal | KLM Laboratories Private Limited | 84725-002 | 84725-0002-0484725-0002-10 |
| Mesalamine | Mesalamine 250 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2791 | 00781-2791-64 |
| Mesalamine | Mesalamine 500 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2793 | 00781-2793-72 |
| Mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | Nuvaila Limited | 84612-175 | 84612-0175-13 |
| Mesalamine | Mesalamine 4 g/60mL | SuspensionRectal | ANI Pharmaceuticals, Inc. | 70954-301 | 70954-0301-20 |
| Mesalamine | Mesalamine 375 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-489 | 31722-0489-12 |
| Mesalamine | Mesalamine 1000 mg/1 | SuppositoryRectal | Rising Pharma Holdings, Inc. | 16571-246 | 16571-0246-0316571-0246-72 |
| Mesalamine | Mesalamine 800 mg/1 | Tablet, Delayed releaseOral | Amneal Pharmaceuticals LLC | 65162-360 | 65162-0360-18 |
| Mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | NorthStar RxLLC | 72603-304 | 72603-0304-01 |
| Mesalamine | Mesalamine 800 mg/1 | Tablet, Delayed releaseOral | AvKARE | 42291-489 | 42291-0489-18 |
Other NDCs under ANDA 091640
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 |
|---|---|---|---|---|
| mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-900 |
| Mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-397 |
| mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-711 |
| mesalamine | Mesalamine 1.2 g/1 | Tablet, Delayed releaseOral | Zydus Lifesciences Limited | 70771-1071 |