Prescription drug · ANDA
Pregabalin NDC 71610-318
Pregabalin 200 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-318-30 | 71610031830 | 30 CAPSULE in 1 BOTTLE (71610-318-30)Marketed from Dec 21, 2023 | |
| 71610-318-46 | 71610031846 | 56 CAPSULE in 1 BOTTLE (71610-318-46)Marketed from Dec 21, 2023 | |
| 71610-318-53 | 71610031853 | 60 CAPSULE in 1 BOTTLE (71610-318-53)Marketed from Aug 12, 2019 |
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)
- Pregabalin
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211384
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 71610-318_9d6ac8b5-77e4-4c4f-9c24-8d3043149146SPL ID 9d6ac8b5-77e4-4c4f-9c24-8d3043149146SPL set ID bf710bcf-75ed-4184-b9c3-81cd05a780a4RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6M
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
N471610031830followed by a unit qualifier and the quantityPackage 71610-0318-30. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 211384
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 |
|---|---|---|---|---|
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-765 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-569 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-568 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-572 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-570 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-571 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-573 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-574 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-575 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-956 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-954 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-955 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-961 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-313 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-957 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-958 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-959 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-962 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-314 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-316 |
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