Prescription drug · ANDA
Pregabalin NDC 67877-463
Pregabalin 50 mg/1 · Capsule · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-463-05 | 67877046305 | 500 CAPSULE in 1 BOTTLE (67877-463-05)Marketed from Oct 2, 2019 | |
| 67877-463-30 | 67877046330 | 30 CAPSULE in 1 BOTTLE (67877-463-30)Marketed from Oct 2, 2019 | |
| 67877-463-33 | 67877046333 | 1 BLISTER PACK in 1 CARTON (67877-463-33) / 10 CAPSULE in 1 BLISTER PACKMarketed from Oct 2, 2019 | |
| 67877-463-38 | 67877046338 | 10 BLISTER PACK in 1 CARTON (67877-463-38) / 10 CAPSULE in 1 BLISTER PACKMarketed from Oct 2, 2019 | |
| 67877-463-90 | 67877046390 | 90 CAPSULE in 1 BOTTLE (67877-463-90)Marketed from Oct 2, 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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- 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 67877-463_a59cea51-015e-4eb2-bdd0-08fa82f32f75SPL ID a59cea51-015e-4eb2-bdd0-08fa82f32f75SPL set ID e48db3c2-7351-41f2-a451-5a8341c4125cRxCUI 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
N467877046305followed by a unit qualifier and the quantityPackage 67877-0463-05. 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 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.
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 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-639 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0185 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Proficient Rx LP | 71205-608 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-681 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-682 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-621 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4481 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-729 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-465 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-462 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-464 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-469 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-466 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-467 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-468 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1462 |
| 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 150 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1466 |
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