Prescription drug · ANDA
pregabalin NDC 14445-173
Pregabalin 25 mg/1 · Capsule · Oral · Indoco Remedies Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14445-173-90 | 14445017390 | 90 CAPSULE in 1 BOTTLE (14445-173-90)Marketed from May 17, 2024 |
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
- Indoco Remedies Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208113
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 14445-173_522b3d6c-10fb-4581-afb7-2e48150b6048SPL ID 522b3d6c-10fb-4581-afb7-2e48150b6048SPL set ID 0a8d9e35-46fd-4c70-bb7f-4e8b754f2794RxCUI 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
N414445017390followed by a unit qualifier and the quantityPackage 14445-0173-90. 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 208113
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 | Indoco Remedies Limited | 14445-123 |
| pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Indoco Remedies Limited | 14445-125 |
| pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Indoco Remedies Limited | 14445-124 |
| pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Indoco Remedies Limited | 14445-126 |
| pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Indoco Remedies Limited | 14445-127 |
| pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Indoco Remedies Limited | 14445-128 |
| pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Indoco Remedies Limited | 14445-174 |