Prescription drug · ANDA
Pregabalin NDC 71205-556
Pregabalin 50 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-556-30 | 71205055630 | 30 CAPSULE in 1 BOTTLE (71205-556-30)Marketed from Apr 23, 2021 | |
| 71205-556-60 | 71205055660 | 60 CAPSULE in 1 BOTTLE (71205-556-60)Marketed from Apr 23, 2021 | |
| 71205-556-90 | 71205055690 | 90 CAPSULE in 1 BOTTLE (71205-556-90)Marketed from Apr 23, 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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 71205-556_f58c99d0-e792-46b7-a67c-c6b1bce50946SPL ID f58c99d0-e792-46b7-a67c-c6b1bce50946SPL set ID 89b8c2d2-4a99-4b97-8b82-c0c36cd0df1bRxCUI 483448UNII 55JG375S6MUPC 0371205556303
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
N471205055630followed by a unit qualifier and the quantityPackage 71205-0556-30. 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 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 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 capsules are indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( …
Excerpt only. Read the full label for complete information.
About NDC 71205-556
- What is NDC 71205-556?
- 71205-556 is the product NDC for Pregabalin, Pregabalin 50 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pregabalin.
- What is the active ingredient?
- Pregabalin.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pregabalin?
- 509 other product NDCs are listed under this name. See all Pregabalin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pregabalin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4749 | 70518-4749-00 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4743 | 70518-4743-00 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-441 | 29300-0441-19 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-439 | 29300-0439-19 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-440 | 29300-0440-19 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-446 | 29300-0446-19 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4715 | 70518-4715-00 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4716 | 70518-4716-00 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-445 | 29300-0445-19 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-442 | 29300-0442-19 |
Other NDCs under ANDA 208677
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 200 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-329 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-580 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-591 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-581 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-330 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-331 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-827 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-485 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Direct Rx | 72189-328 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-507 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-719 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-964 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8195 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8196 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-645 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8197 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-646 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8198 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-647 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8199 |
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