Prescription drug · ANDA
Pregabalin NDC 68788-8360
Pregabalin 100 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8360-1 | 68788836001 | 100 CAPSULE in 1 BLISTER PACK (68788-8360-1)Marketed from Feb 1, 2023 | |
| 68788-8360-3 | 68788836003 | 30 CAPSULE in 1 BOTTLE (68788-8360-3)Marketed from Feb 1, 2023 | |
| 68788-8360-6 | 68788836006 | 60 CAPSULE in 1 BOTTLE (68788-8360-6)Marketed from Feb 1, 2023 | |
| 68788-8360-9 | 68788836009 | 90 CAPSULE in 1 BOTTLE (68788-8360-9)Marketed from Feb 1, 2023 |
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)
- Pregabalin
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207799
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 68788-8360_582d8992-18e4-4886-bc7d-d668fa763e44SPL ID 582d8992-18e4-4886-bc7d-d668fa763e44SPL set ID e8e272a4-c181-4573-822b-2bb315b6ad37RxCUI 483438UNII 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
N468788836001followed by a unit qualifier and the quantityPackage 68788-8360-01. 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 .
Indications (excerpt from the label)
Pregabalin is 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 is 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 68788-8360
- What is NDC 68788-8360?
- 68788-8360 is the product NDC for Pregabalin, Pregabalin 100 mg/1 capsule, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 100 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-442 | 29300-0442-19 |
| 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 75 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-441 | 29300-0441-19 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-446 | 29300-0446-19 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-443 | 29300-0443-19 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-444 | 29300-0444-19 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-445 | 29300-0445-19 |
Other NDCs under ANDA 207799
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 | Clinical Solutions Wholesale, LLC | 58118-1462 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1466 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1463 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1464 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1465 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1467 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0417 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0160 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0421 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0185 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8391 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3597 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3643 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3636 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3647 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3646 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1740 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1745 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1751 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1758 |
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