Prescription drug · ANDA
Etodolac NDC 71205-743
Etodolac 200 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-743-20 | 71205074320 | 20 CAPSULE in 1 BOTTLE (71205-743-20)Marketed from Jan 16, 2023 | |
| 71205-743-30 | 71205074330 | 30 CAPSULE in 1 BOTTLE (71205-743-30)Marketed from Jan 16, 2023 | |
| 71205-743-60 | 71205074360 | 60 CAPSULE in 1 BOTTLE (71205-743-60)Marketed from Jan 16, 2023 | |
| 71205-743-90 | 71205074390 | 90 CAPSULE in 1 BOTTLE (71205-743-90)Marketed from Jan 16, 2023 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075126
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-743_0fce1aea-5de2-4acb-8a21-2b775c4adb25SPL ID 0fce1aea-5de2-4acb-8a21-2b775c4adb25SPL set ID 0fce1aea-5de2-4acb-8a21-2b775c4adb25RxCUI 197684UNII 2M36281008UPC 0371205743901
- 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
N471205074320followed by a unit qualifier and the quantityPackage 71205-0743-20. 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 other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac capsules are indicated: • For acute and long-term use in the management of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis • For the management of acute pain
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075126
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 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1756 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1757 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-3641 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2132 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-250 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-251 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1935 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1936 |