Prescription drug · ANDA
Etodolac NDC 72789-538
Etodolac 400 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-538-28 | 72789053828 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-538-28)Marketed from Dec 16, 2025 |
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)
- Etodolac
- Generic name (nonproprietary)
- etodolac
- Active ingredients
- Etodolac — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 72789-538_4616c7ad-be25-7ac0-e063-6394a90ab9edSPL ID 4616c7ad-be25-7ac0-e063-6394a90ab9edSPL set ID 80e9d756-9278-48bb-bfdd-7d070ae0f341RxCUI 197686UNII 2M36281008UPC 0372789538280
- 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
N472789053828followed by a unit qualifier and the quantityPackage 72789-0538-28. 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 etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac tablets, USP are indicated: For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis For the management of acute pain
Excerpt only. Read the full label for complete information.
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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0190 |
| 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. | 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 |