Prescription drug · ANDA
Etodolac NDC 63187-374
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 |
|---|---|---|---|
| 63187-374-30 | 63187037430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-30)Marketed from Sep 1, 2016 | |
| 63187-374-60 | 63187037460 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-60)Marketed from Sep 1, 2016 | |
| 63187-374-90 | 63187037490 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-90)Marketed from Sep 1, 2016 |
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 LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091134
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-374_dd9d2003-9288-4d96-8910-705710883378SPL ID dd9d2003-9288-4d96-8910-705710883378SPL set ID 4712e069-83b6-4052-8d95-f59ab1dba744RxCUI 310245UNII 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
N463187037430followed by a unit qualifier and the quantityPackage 63187-0374-30. 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, USP and other treatment options before deciding to use etodolac extended-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac extended-release tablets, USP 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.
Other NDCs under ANDA 091134
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 | Bryant Ranch Prepack | 63629-8598 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coated, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3731 |
| Etodolac | Etodolac 600 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 65841-779 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 65841-777 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 65841-778 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-298 |
| Etodolac | Etodolac 600 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-273 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-271 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-272 |
| Etodolac | Etodolac 600 mg/1 | Tablet, Film coated, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0381 |