Prescription drug · ANDA
Pregabalin NDC 65862-763
Pregabalin 200 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-763-05 | 65862076305 | 500 CAPSULE in 1 BOTTLE (65862-763-05)Marketed from Mar 29, 2023 | |
| 65862-763-78 | 65862076378 | 10 BLISTER PACK in 1 CARTON (65862-763-78) / 10 CAPSULE in 1 BLISTER PACK (65862-763-10)Marketed from Mar 29, 2023 | |
| 65862-763-90 | 65862076390 | 90 CAPSULE in 1 BOTTLE (65862-763-90)Marketed from Mar 29, 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)
- Pregabalin
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205321
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 65862-763_03c24a38-f80a-4acb-ab38-c747c13125d4SPL ID 03c24a38-f80a-4acb-ab38-c747c13125d4SPL set ID 11034861-eef2-4996-8082-afc3c1769171RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0365862758903
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
N465862076305followed by a unit qualifier and the quantityPackage 65862-0763-05. 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 .
Indications (excerpt from the label)
Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older (1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205321
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 50 mg/1 | CapsuleOral | Coupler LLC | 67046-1494 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-758 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-762 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-759 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-760 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-761 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-764 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-765 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-871 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0760 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0758 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0759 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0763 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0761 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0762 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0764 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0765 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1628 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1680 |