Prescription drug · ANDA
Pregabalin NDC 68788-8472
Pregabalin 50 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8472-1 | 68788847201 | 100 CAPSULE in 1 BOTTLE (68788-8472-1)Marketed from Jun 29, 2023 | |
| 68788-8472-3 | 68788847203 | 30 CAPSULE in 1 BOTTLE (68788-8472-3)Marketed from Jun 29, 2023 | |
| 68788-8472-6 | 68788847206 | 60 CAPSULE in 1 BOTTLE (68788-8472-6)Marketed from Jun 29, 2023 | |
| 68788-8472-9 | 68788847209 | 90 CAPSULE in 1 BOTTLE (68788-8472-9)Marketed from Jun 29, 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 — 50 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 206912
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 68788-8472_5c88b24d-1b89-4ec5-9945-a45999781c17SPL ID 5c88b24d-1b89-4ec5-9945-a45999781c17SPL set ID 7f29991e-3bf5-4e48-8fa3-6d4e932ed6deRxCUI 483448UNII 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
N468788847201followed by a unit qualifier and the quantityPackage 68788-8472-01. 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 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) ( ) • Postherpetic neuralgia (PHN) ( ) • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( ) • Fibromyalgia ( ) • Neuropathic pain associated with spinal cord injury ( )…
Excerpt only. Read the full label for complete information.
About NDC 68788-8472
- What is NDC 68788-8472?
- 68788-8472 is the product NDC for Pregabalin, Pregabalin 50 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?
- 507 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 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 100 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-442 | 29300-0442-19 |
| 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 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-446 | 29300-0446-19 |
Other NDCs under ANDA 206912
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 | Camber Pharmaceuticals, Inc. | 31722-610 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-611 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-612 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-613 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-614 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-615 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-616 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-617 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7983 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-768 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8667 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4272 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4585 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4654 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4715 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4716 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4743 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4749 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1788 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1789 |
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