Prescription drug · ANDA
Valproic (valproic acid) NDC 71610-906
Valproic acid 250 mg/1 · Capsule, Liquid filled · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-906-30 | 71610090630 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-30)Marketed from May 7, 2025 | |
| 71610-906-53 | 71610090653 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-53)Marketed from May 7, 2025 | |
| 71610-906-60 | 71610090660 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-60)Marketed from May 7, 2025 | |
| 71610-906-70 | 71610090670 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-70)Marketed from May 23, 2025 | |
| 71610-906-80 | 71610090680 | 180 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-80)Marketed from May 7, 2025 | |
| 71610-906-90 | 71610090690 | 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-90)Marketed from May 23, 2025 |
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)
- Valproic
- Generic name (nonproprietary)
- valproic acid
- Active ingredients
- Valproic acid — 250 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073229
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71610-906_35d13593-172f-3a08-e063-6294a90a72feSPL ID 35d13593-172f-3a08-e063-6294a90a72feSPL set ID 34a0d45a-4388-7d8b-e063-6394a90a6c3fRxCUI 1099681UNII 614OI1Z5WI
- Pharmacologic class
- Anti-epileptic Agent; Mood Stabilizer
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
N471610090630followed by a unit qualifier and the quantityPackage 71610-0906-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Valproic Acid is an anti-epileptic drug indicated for: Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1 ) 1.1 Epilepsy Valproic Acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic Acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 073229
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 |
|---|---|---|---|---|
| valproic acid | Valproic acid 250 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-085 |
| Valproicvalproic acid | Valproic acid 250 mg/1 | Capsule, Liquid filledOral | Actavis Pharma, Inc. | 0591-4012 |
| valproic acid | Valproic acid 250 mg/1 | CapsuleOral | Upsher-Smith Laboratories, LLC | 0832-0310 |
| Valproic Acid | Valproic acid 250 mg/1 | CapsuleOral | Direct_Rx | 72189-010 |