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 | 6586207630565862076305 | 500 CAPSULE in 1 BOTTLE (65862-763-05)Marketed from Mar 29, 2023 | |
| 65862-763-78 | 6586207637865862076378 | 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 | 6586207639065862076390 | 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 LimitedNDC labeler code 65862
- 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.
About NDC 65862-763
- What is NDC 65862-763?
- 65862-763 is the product NDC for Pregabalin, Pregabalin 200 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pregabalin.
- What is the active ingredient?
- Pregabalin.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pregabalin?
- 509 other product NDCs are listed under this name. See all Pregabalin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pregabalin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4778 | 70518-4778-00 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4749 | 70518-4749-00 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4743 | 70518-4743-00 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4715 | 70518-4715-00 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4716 | 70518-4716-00 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-439 | 29300-0439-19 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-440 | 29300-0440-19 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-444 | 29300-0444-19 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-441 | 29300-0441-19 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-442 | 29300-0442-19 |
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 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1680 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Coupler LLC | 67046-1494 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-760 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-758 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-759 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-761 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-762 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-764 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-765 |
| 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 75 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0760 |
| 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 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-871 |