Prescription drug · ANDA
Mesalamine NDC 63629-8679
Kit · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8679-1 | 63629867901 | 4 CARTON in 1 KIT (63629-8679-1) / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKETMarketed from Aug 2, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Dosage form
- Kit
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076751
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-8679_3735ed2d-e468-4890-813a-991f3aa5fd48SPL ID 3735ed2d-e468-4890-813a-991f3aa5fd48SPL set ID 1e561474-6169-410e-b83d-7e96d375831dRxCUI 238151
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N463629867901followed by a unit qualifier and the quantityPackage 63629-8679-01. 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)
INDICATIONS AND USAGE Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076751
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 | — | Kit | Padagis Israel Pharmaceuticals Ltd | 45802-923 |
| Mesalamine | — | Kit | Padagis Israel Pharmaceuticals Ltd | 45802-929 |
| Mesalamine | Mesalamine 4 g/60mL | EnemaRectal | Padagis Israel Pharmaceuticals Ltd | 45802-098 |
| Mesalamine | — | Kit | Bryant Ranch Prepack | 63629-8678 |