Prescription drug · ANDA
Indomethacin NDC 71335-1568
Indomethacin 50 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1568-1 | 71335156801 | 21 CAPSULE in 1 BOTTLE (71335-1568-1)Marketed from May 19, 2016 | |
| 71335-1568-2 | 71335156802 | 42 CAPSULE in 1 BOTTLE (71335-1568-2)Marketed from May 19, 2016 | |
| 71335-1568-3 | 71335156803 | 30 CAPSULE in 1 BOTTLE (71335-1568-3)Marketed from May 19, 2016 | |
| 71335-1568-4 | 71335156804 | 60 CAPSULE in 1 BOTTLE (71335-1568-4)Marketed from May 19, 2016 | |
| 71335-1568-5 | 71335156805 | 90 CAPSULE in 1 BOTTLE (71335-1568-5)Marketed from May 19, 2016 | |
| 71335-1568-6 | 71335156806 | 14 CAPSULE in 1 BOTTLE (71335-1568-6)Marketed from May 19, 2016 | |
| 71335-1568-7 | 71335156807 | 20 CAPSULE in 1 BOTTLE (71335-1568-7)Marketed from May 19, 2016 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091240
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1568_a78e0fc3-6693-4308-82ed-11084d6d5d62SPL ID a78e0fc3-6693-4308-82ed-11084d6d5d62SPL set ID 67b16cf2-e24c-4fe3-8d74-e63549b7659fRxCUI 197817, 197818UNII 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
N471335156801followed by a unit qualifier and the quantityPackage 71335-1568-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Indomethacin Capsules are indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) • Acute gouty arthritis Indomethacin Capsule is a nonsteroidal anti-inflammatory drug indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) • Acute gouty arthritis ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091240
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 50 mg/1 | CapsuleOral | Proficient Rx LP | 63187-282 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8092 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0992 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8993 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8994 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | DIRECT RX | 61919-130 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-542 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-543 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4055 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | XLCare Pharmaceuticals Inc. | 72865-148 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | XLCare Pharmaceuticals Inc. | 72865-149 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1913 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1914 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-916 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0050 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0051 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0053 |
| Indomethacin | Indomethacin 25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-215 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0747 |
| Indomethacin | Indomethacin 50 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 66267-120 |
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