Prescription drug · ANDA
Flurbiprofen NDC 64950-218
Flurbiprofen 100 mg/1 · Tablet · Oral · Genus Lifesciences
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64950-218-10 | 6495002181064950021810 | 100 TABLET in 1 BOTTLE (64950-218-10)Marketed from Nov 1, 2024 |
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)
- Flurbiprofen
- Generic name (nonproprietary)
- flurbiprofen
- Active ingredients
- Flurbiprofen — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Genus LifesciencesNDC labeler code 64950
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074431
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 64950-218_d3fa269f-43c4-4862-b4d2-ec5b04d050c8SPL ID d3fa269f-43c4-4862-b4d2-ec5b04d050c8SPL set ID 4670cf21-eb0e-4f5a-ab22-41af85733525RxCUI 197724UNII 5GRO578KLP
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N464950021810followed by a unit qualifier and the quantityPackage 64950-0218-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Flurbiprofen tablets are indicated: For relief of the signs and symptoms of rheumatoid arthritis. For relief of the signs and symptoms of osteoarthritis. Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of rheumatoid arthritis ( 1 ) Relief of the signs and symptoms of osteoarthritis ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 64950-218
- What is NDC 64950-218?
- 64950-218 is the product NDC for Flurbiprofen, Flurbiprofen 100 mg/1 tablet, listed with the FDA by Genus Lifesciences. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flurbiprofen.
- What is the active ingredient?
- Flurbiprofen.
- Who is the labeler?
- Genus Lifesciences, NDC labeler code 64950. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Flurbiprofen?
- 1 other product NDC are listed under this name. See all Flurbiprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Flurbiprofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flurbiprofen | Flurbiprofen 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4436 | 68071-4436-04 |
Other NDCs under ANDA 074431
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 |
|---|---|---|---|---|
| Flurbiprofen | Flurbiprofen 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4436 |
| Lurbiroflurbiprofen | Flurbiprofen 100 mg/1 | TabletOral | IPG Pharmaceuticals, Inc. | 71085-082 |