Prescription drug · ANDA
Pregabalin NDC 60219-1316
Pregabalin 225 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1316-9 | 60219131609 | 90 CAPSULE in 1 BOTTLE (60219-1316-9)Marketed from Jul 19, 2019 |
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 — 225 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209743
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 60219-1316_05638bed-2d09-47d9-8378-1265cf468389SPL ID 05638bed-2d09-47d9-8378-1265cf468389SPL set ID 3099759f-cb24-40e8-b482-9388c38c73b9RxCUI 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
N460219131609followed by a unit qualifier and the quantityPackage 60219-1316-09. 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 209743
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 | Proficient Rx LP | 71205-816 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Direct_Rx | 72189-033 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Direct_Rx | 72189-115 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1310 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1314 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1311 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1312 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1313 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1315 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1316 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1317 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1312 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1310 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1311 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1313 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Direct_Rx | 72189-164 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1314 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1315 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0025 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1317 |
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