Prescription drug · ANDA
Dolobid (diflunisal) NDC 74157-009
Diflunisal 250 mg/1 · Tablet, Film coated · Oral · INA Pharmaceutics Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 74157-009-60 | 74157000960 | 60 TABLET, FILM COATED in 1 BOTTLE (74157-009-60)Marketed from Aug 19, 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)
- Dolobid
- Generic name (nonproprietary)
- diflunisal
- Active ingredients
- Diflunisal — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- INA Pharmaceutics Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202845
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 74157-009_4081e337-1003-6e39-e063-6294a90a4698SPL ID 4081e337-1003-6e39-e063-6294a90a4698SPL set ID 725234b2-0e23-45c3-a42d-eb4e62273f9bRxCUI 105823, 197602, 249400, 2691103UNII 7C546U4DENUPC 0374157101607, 0374157009606
- 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
N474157000960followed by a unit qualifier and the quantityPackage 74157-0009-60. 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)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Dolobid and other treatment options before deciding to use Dolobid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Dolobid is indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202845
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 |
|---|---|---|---|---|
| Diflunisal | Diflunisal 500 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-456 |
| Dolobiddiflunisal | Diflunisal 375 mg/1 | Tablet, Film coatedOral | INA Pharmaceutics Inc | 74157-101 |
| diflunisal | Diflunisal 500 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-673 |