Prescription drug · ANDA
Pregabalin NDC 76282-568
Pregabalin 25 mg/1 · Capsule · Oral · Exelan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-568-05 | 76282056805 | 500 CAPSULE in 1 BOTTLE (76282-568-05)Marketed from Jul 19, 2019 | |
| 76282-568-90 | 76282056890 | 90 CAPSULE in 1 BOTTLE (76282-568-90)Marketed from Jul 19, 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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211384
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 76282-568_b26b72af-62e4-4eb5-9cb8-e4eb05a22435SPL ID b26b72af-62e4-4eb5-9cb8-e4eb05a22435SPL set ID 3fdc6e94-2504-416c-81dd-2db9bc194ebbRxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0376282569901, 0376282571904, 0376282570907, 0376282572901, 0376282568904, 0376282575902, 0376282574905, 0376282573908
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
N476282056805followed by a unit qualifier and the quantityPackage 76282-0568-05. 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 I 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 211384
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 75 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-765 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-569 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-572 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-570 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-571 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-573 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-574 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Exelan Pharmaceuticals Inc. | 76282-575 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-956 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-954 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-955 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-961 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-313 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-957 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-958 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-959 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-318 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Cipla USA, Inc. | 69097-962 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-314 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-316 |
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