Prescription drug · ANDA
Etodolac NDC 65841-777
Etodolac 400 mg/1 · Tablet, Film coated, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-777-01 | 65841077701 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-01)Marketed from Feb 15, 2014 | |
| 65841-777-05 | 65841077705 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-05)Marketed from Feb 15, 2014 | |
| 65841-777-10 | 65841077710 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-10)Marketed from Feb 15, 2014 | |
| 65841-777-14 | 65841077714 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-777-14)Marketed from Feb 15, 2014 | |
| 65841-777-77 | 65841077777 | 100 BLISTER PACK in 1 CARTON (65841-777-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65841-777-30)Marketed from Feb 15, 2014 |
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
- Zydus Lifesciences Limited
- 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 65841-777_12ad7193-e8e8-49cd-871c-e7a4c47f32c4SPL ID 12ad7193-e8e8-49cd-871c-e7a4c47f32c4SPL set ID 0c5f8631-f013-4bbb-b610-0a8a1311844eRxCUI 310245, 310247, 359500UNII 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
N465841077701followed by a unit qualifier and the quantityPackage 65841-0777-01. 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 .
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 | 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 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 65841-778 |
| Etodolac | Etodolac 600 mg/1 | Tablet, Film coated, Extended releaseOral | Zydus Lifesciences Limited | 65841-779 |
| 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 | Proficient Rx LP | 63187-374 |
| 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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0381 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-298 |