Prescription drug · ANDA
Pregabalin NDC 71610-799
Pregabalin 75 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-799-30 | 71610079930 | 30 CAPSULE in 1 BOTTLE (71610-799-30)Marketed from Feb 22, 2024 | |
| 71610-799-46 | 71610079946 | 56 CAPSULE in 1 BOTTLE (71610-799-46)Marketed from Feb 22, 2024 | |
| 71610-799-53 | 71610079953 | 60 CAPSULE in 1 BOTTLE (71610-799-53)Marketed from Feb 22, 2024 | |
| 71610-799-54 | 71610079954 | 84 CAPSULE in 1 BOTTLE (71610-799-54)Marketed from Feb 22, 2024 | |
| 71610-799-70 | 71610079970 | 120 CAPSULE in 1 BOTTLE (71610-799-70)Marketed from Feb 22, 2024 | |
| 71610-799-92 | 71610079992 | 270 CAPSULE in 1 BOTTLE (71610-799-92)Marketed from Feb 22, 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 — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- 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 71610-799_11fe25df-ae2e-b1da-e063-6294a90ab6cfSPL ID 11fe25df-ae2e-b1da-e063-6294a90ab6cfSPL set ID 11fe25cd-1aca-0e63-e063-6394a90a197eRxCUI 483450UNII 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
N471610079930followed by a unit qualifier and the quantityPackage 71610-0799-30. 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) ( 1 ) Postherp…
Excerpt only. Read the full label for complete information.
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 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-808 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0433 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-304 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0177 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Proficient Rx LP | 71205-870 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-869 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-874 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-871 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-872 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Proficient Rx LP | 71205-873 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Proficient Rx LP | 71205-876 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-323 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Proficient Rx LP | 71205-875 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3118 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-800 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-820 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Proficient Rx LP | 71205-396 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-677 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7522 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7520 |
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