Prescription drug · ANDA
Etodolac NDC 80425-0190
Etodolac 400 mg/1 · Tablet, Film coated · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0190-2 | 80425019002 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0190-2)Marketed from Feb 17, 2024 |
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)
- Etodolac
- Generic name (nonproprietary)
- etodolac
- Active ingredients
- Etodolac — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076004
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0190_2a99a7c1-c4c5-2b01-e063-6294a90aa3b8SPL ID 2a99a7c1-c4c5-2b01-e063-6294a90aa3b8SPL set ID d83d9f30-c367-f8b3-e053-2a95a90a1f40RxCUI 197686UNII 2M36281008
- 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
N480425019002followed by a unit qualifier and the quantityPackage 80425-0190-02. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 076004
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 |
|---|---|---|---|---|
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1790 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-538 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-856 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Medsource Pharmaceuticals | 45865-206 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-804 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3845 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-736 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8846 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4542 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-467 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-578 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0399 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0041 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0126 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0102 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-671 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | St. Marys Medical Park Pharmacy | 60760-552 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8805 |