Prescription drug · ANDA
Pregabalin NDC 71335-1822
Pregabalin 200 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1822-1 | 71335182201 | 30 CAPSULE in 1 BOTTLE (71335-1822-1)Marketed from Apr 22, 2021 | |
| 71335-1822-2 | 71335182202 | 60 CAPSULE in 1 BOTTLE (71335-1822-2)Marketed from Apr 13, 2021 | |
| 71335-1822-3 | 71335182203 | 90 CAPSULE in 1 BOTTLE (71335-1822-3)Marketed from Apr 15, 2021 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-1822_99a3d5ea-2eb0-4298-b112-93d0e3233eb7SPL ID 99a3d5ea-2eb0-4298-b112-93d0e3233eb7SPL set ID b2d45d41-a787-4912-962d-0bd98b70d58aRxCUI 483446UNII 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
N471335182201followed by a unit qualifier and the quantityPackage 71335-1822-01. 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) ( 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 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 150 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0178 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1788 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1791 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1789 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1790 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1792 |
| 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 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4272 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4749 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 82804-170 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3158 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-768 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Proficient Rx LP | 82804-184 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-354 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-352 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-353 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-358 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-355 |
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