Prescription drug · ANDA
Valproic (Valproic acid) NDC 0591-4012
Valproic acid 250 mg/1 · Capsule, Liquid filled · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-4012-01 | 00591401201 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0591-4012-01)Marketed from Sep 8, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- 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 0591-4012_8c8b8043-7c2a-44cc-80e7-fdfa0236287eSPL ID 8c8b8043-7c2a-44cc-80e7-fdfa0236287eSPL set ID cef3e335-5891-412f-89c4-79fcd2f145b7RxCUI 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
N400591401201followed by a unit qualifier and the quantityPackage 00591-4012-01. 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.
About NDC 0591-4012
- What is NDC 0591-4012?
- 0591-4012 is the product NDC for Valproic (valproic acid), Valproic acid 250 mg/1 capsule, liquid filled, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valproic (Valproic Acid).
- What is the active ingredient?
- Valproic acid.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valproic?
- 1 other product NDC are listed under this name. See all Valproic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valproic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valproicvalproic acid | Valproic acid 250 mg/1 | Capsule, Liquid filledOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-906 | 71610-0906-3071610-0906-5371610-0906-60+3 more |
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 | Direct_Rx | 72189-010 |
| valproic acid | Valproic acid 250 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-085 |
| valproic acid | Valproic acid 250 mg/1 | CapsuleOral | Upsher-Smith Laboratories, LLC | 0832-0310 |
| Valproicvalproic acid | Valproic acid 250 mg/1 | Capsule, Liquid filledOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-906 |