Prescription drug · ANDA
Etodolac NDC 76385-118
Etodolac 400 mg/1 · Tablet, Film coated · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76385-118-01 | 76385011801 | 100 TABLET, FILM COATED in 1 BOTTLE (76385-118-01)Marketed from Aug 1, 2021 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210704
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 76385-118_c135c9a7-8a1d-4383-b373-a1dbf711567aSPL ID c135c9a7-8a1d-4383-b373-a1dbf711567aSPL set ID 18215cb7-c833-4a98-a61d-4bedf518a380RxCUI 197686, 199390UNII 2M36281008UPC 0376385118013, 0376385119010
- 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
N476385011801followed by a unit qualifier and the quantityPackage 76385-0118-01. 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 tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac 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 210704
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 | A-S Medication Solutions | 50090-6739 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 76385-119 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2259 |