Prescription drug · ANDA
Pregabalin NDC 82804-944
Pregabalin 50 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-944-00 | 82804094400 | 100 CAPSULE in 1 BOTTLE (82804-944-00)Marketed from May 27, 2026 | |
| 82804-944-11 | 82804094411 | 1000 CAPSULE in 1 BOTTLE (82804-944-11)Marketed from May 27, 2026 | |
| 82804-944-30 | 82804094430 | 30 CAPSULE in 1 BOTTLE (82804-944-30)Marketed from May 27, 2026 | |
| 82804-944-55 | 82804094455 | 500 CAPSULE in 1 BOTTLE (82804-944-55)Marketed from May 27, 2026 | |
| 82804-944-60 | 82804094460 | 60 CAPSULE in 1 BOTTLE (82804-944-60)Marketed from May 27, 2026 | |
| 82804-944-67 | 82804094467 | 270 CAPSULE in 1 BOTTLE (82804-944-67)Marketed from May 27, 2026 | |
| 82804-944-72 | 82804094472 | 120 CAPSULE in 1 BOTTLE (82804-944-72)Marketed from May 27, 2026 | |
| 82804-944-78 | 82804094478 | 180 CAPSULE in 1 BOTTLE (82804-944-78)Marketed from May 27, 2026 | |
| 82804-944-90 | 82804094490 | 90 CAPSULE in 1 BOTTLE (82804-944-90)Marketed from May 27, 2026 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212988
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 82804-944_34846423-e747-42c5-9bcd-f99c557c4f67SPL ID 34846423-e747-42c5-9bcd-f99c557c4f67SPL set ID 34846423-e747-42c5-9bcd-f99c557c4f67RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0382804947300, 0382804946303, 0382804944309, 0382804950300, 0382804949304, 0382804943302
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
N482804094400followed by a unit qualifier and the quantityPackage 82804-0944-00. 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 212988
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 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-946 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Proficient Rx LP | 82804-943 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 82804-945 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Proficient Rx LP | 82804-950 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Proficient Rx LP | 82804-947 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Proficient Rx LP | 82804-948 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Proficient Rx LP | 82804-949 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-424 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-425 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-426 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-427 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-431 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-428 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-429 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-430 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Eskayef Pharmaceuticals Limited | 72658-0808 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Eskayef Pharmaceuticals Limited | 72658-0812 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Eskayef Pharmaceuticals Limited | 72658-0809 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Eskayef Pharmaceuticals Limited | 72658-0810 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Eskayef Pharmaceuticals Limited | 72658-0811 |
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