Prescription drug · ANDA
Indomethacin NDC 71335-9754
Indomethacin 75 mg/1 · Capsule, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9754-1 | 71335975401 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-1)Marketed from Sep 21, 2023 | |
| 71335-9754-2 | 71335975402 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-2)Marketed from Apr 9, 2024 | |
| 71335-9754-3 | 71335975403 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-3)Marketed from Aug 1, 2023 | |
| 71335-9754-4 | 71335975404 | 10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-4)Marketed from Apr 9, 2024 | |
| 71335-9754-5 | 71335975405 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-5)Marketed from Apr 9, 2024 | |
| 71335-9754-6 | 71335975406 | 15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-6)Marketed from Apr 9, 2024 | |
| 71335-9754-7 | 71335975407 | 20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-7)Marketed from Apr 9, 2024 | |
| 71335-9754-8 | 71335975408 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-8)Marketed from Apr 9, 2024 | |
| 71335-9754-9 | 71335975409 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-9)Marketed from Apr 9, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Indomethacin
- Generic name (nonproprietary)
- indomethacin
- Active ingredients
- Indomethacin — 75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079175
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-9754_6f8b687c-33f2-4936-ac92-aceadb1a90adSPL ID 6f8b687c-33f2-4936-ac92-aceadb1a90adSPL set ID 41af7776-36bc-4820-b635-e7c69f26997eRxCUI 310992UNII XXE1CET956
- 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
N471335975401followed by a unit qualifier and the quantityPackage 71335-9754-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 079175
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 |
|---|---|---|---|---|
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | American Health Packaging | 68084-411 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 55289-469 |
| Indomethacin | Indomethacin 75 mg/1 | Capsule, Extended releaseOral | KVK-Tech, Inc. | 10702-016 |