Prescription drug · ANDA
Etodolac NDC 80425-0551
Etodolac 400 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0551-1 | 80425055101 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0551-1)Marketed from Aug 29, 2025 |
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 075074
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0551_3d87cc75-7a10-46a2-e063-6294a90a6d49SPL ID 3d87cc75-7a10-46a2-e063-6294a90a6d49SPL set ID 3d865ff0-fc45-1e95-e063-6294a90a8e18RxCUI 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
N480425055101followed by a unit qualifier and the quantityPackage 80425-0551-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac Capsules and Tablets 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 075074
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 500 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-779 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-795 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-816 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-311 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-312 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4291 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-859 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 51672-4018 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 51672-4036 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8673 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1958 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1489 |