Prescription drug · ANDA
Pregabalin NDC 71205-621
Pregabalin 75 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-621-30 | 71205062130 | 30 CAPSULE in 1 BOTTLE (71205-621-30)Marketed from Nov 17, 2021 | |
| 71205-621-60 | 71205062160 | 60 CAPSULE in 1 BOTTLE (71205-621-60)Marketed from Nov 17, 2021 | |
| 71205-621-90 | 71205062190 | 90 CAPSULE in 1 BOTTLE (71205-621-90)Marketed from Nov 17, 2021 |
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 — 75 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 207799
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 71205-621_4702a3a6-2275-4978-83f9-1298d54ffa6aSPL ID 4702a3a6-2275-4978-83f9-1298d54ffa6aSPL set ID a1545bbb-b337-4760-ab4c-fb76ab019337RxCUI 483450UNII 55JG375S6MUPC 0371205621605
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
N471205062130followed by a unit qualifier and the quantityPackage 71205-0621-30. 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 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 17 years of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pregabalin is indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) • Postherpetic n…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207799
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 | 71205-639 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0185 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Proficient Rx LP | 71205-608 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-681 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-682 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4481 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-729 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-465 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-462 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-463 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-464 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-469 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-466 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-467 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-468 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1462 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1463 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1464 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1465 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1466 |
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