Prescription drug · ANDA
Pregabalin NDC 82619-125
Pregabalin 100 mg/1 · Capsule · Oral · Creekwood Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82619-125-01 | 82619012501 | 90 CAPSULE in 1 BOTTLE (82619-125-01)Marketed from Sep 20, 2024 | |
| 82619-125-02 | 82619012502 | 500 CAPSULE in 1 BOTTLE (82619-125-02)Marketed from Sep 20, 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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213423
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 82619-125_40b92ce3-6161-36b7-e063-6394a90af51eSPL ID 40b92ce3-6161-36b7-e063-6394a90af51eSPL set ID bfe4108e-b2d2-4059-be16-21d3276c3ae4RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0382619124026, 0382619129021, 0382619128017, 0382619127010, 0382619129014, 0382619125023, 0382619127027, 0382619126013, 0382619122022, 0382619126020, 0382619125016, 0382619123012, 0382619128024, 0382619123029, 0382619122015, 0382619124019
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
N482619012501followed by a unit qualifier and the quantityPackage 82619-0125-01. 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 capsule 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 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 213423
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 50 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-123 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-122 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-124 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-126 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-127 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-128 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-129 |