Prescription drug · ANDA
Etodolac NDC 71205-140
Etodolac 400 mg/1 · Tablet, Film coated, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-140-30 | 7120501403071205014030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-30)Marketed from Oct 31, 2018 | |
| 71205-140-60 | 7120501406071205014060 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-60)Marketed from Oct 31, 2018 | |
| 71205-140-90 | 7120501409071205014090 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-90)Marketed from Oct 31, 2018 |
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, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075665
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-140_524617eb-4404-4d2e-8d0c-478294af8a27SPL ID 524617eb-4404-4d2e-8d0c-478294af8a27SPL set ID 5a040d8e-8d0c-442f-b4e5-161aa7ccbe9aRxCUI 310245UNII 2M36281008UPC 0371205140304
- 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
N471205014030followed by a unit qualifier and the quantityPackage 71205-0140-30. 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 extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac extended-release tablets are indicated: * For relief of signs and symptoms of juvenile arthritis * For relief of the signs and symptoms of rheumatoid arthritis * For relief of the signs and symptoms of osteoarthritis
Excerpt only. Read the full label for complete information.
About NDC 71205-140
- What is NDC 71205-140?
- 71205-140 is the product NDC for Etodolac, Etodolac 400 mg/1 tablet, film coated, extended release, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Etodolac.
- What is the active ingredient?
- Etodolac.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Etodolac?
- 100 other product NDCs are listed under this name. See all Etodolac NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Etodolac products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-461 | 59651-0461-01 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-462 | 59651-0462-01 |
| etodolac | Etodolac 400 mg/1 | TabletOral | Ipca Laboratories Limited | 83980-029 | 83980-0029-0183980-0029-1083980-0029-13 |
| etodolac | Etodolac 500 mg/1 | TabletOral | Ipca Laboratories Limited | 83980-030 | 83980-0030-0183980-0030-0583980-0030-13 |
| etodolac | Etodolac 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-8037 | 50090-8037-01 |
| etodolac | Etodolac 200 mg/1 | CapsuleOral | Ipca Laboratories Limited | 83980-031 | 83980-0031-0183980-0031-0583980-0031-13 |
| etodolac | Etodolac 300 mg/1 | CapsuleOral | Ipca Laboratories Limited | 83980-032 | 83980-0032-0183980-0032-0583980-0032-13 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4542 | 70518-4542-00 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0551 | 80425-0551-01 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8846 | 68788-8846-0168788-8846-0268788-8846-03+2 more |
Other NDCs under ANDA 075665
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 600 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-1118 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-1122 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coated, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-7172 |