Prescription drug · ANDA
Pregabalin NDC 39328-090
Pregabalin 20 mg/mL · Solution · Oral · Patrin Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39328-090-16 | 39328009016 | 1 BOTTLE, PLASTIC in 1 CARTON (39328-090-16) / 473 mL in 1 BOTTLE, PLASTICMarketed from Jun 14, 2022 |
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 — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Patrin Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212604
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 39328-090_3a08157d-abaf-445c-b333-c209ef961bc0SPL ID 3a08157d-abaf-445c-b333-c209ef961bc0SPL set ID d92c94e5-e542-4177-afa8-fa00ba17634cRxCUI 898715UNII 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
N439328009016followed by a unit qualifier and the quantityPackage 39328-0090-16. 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 oral solution 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 4 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 oral solution is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) P…
Excerpt only. Read the full label for complete information.