Prescription drug · ANDA
Valproic Acid NDC 62559-266
Valproic acid 250 mg/5mL · Solution · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-266-16 | 62559026616 | 473 mL in 1 BOTTLE (62559-266-16)Marketed from Jan 2, 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)
- Valproic Acid
- Generic name (nonproprietary)
- valproic acid
- Active ingredients
- Valproic acid — 250 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 62559
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073178
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 62559-266_36e8a44c-2c80-4c44-8cad-9ea6de9807c3SPL ID 36e8a44c-2c80-4c44-8cad-9ea6de9807c3SPL set ID 2314af65-b928-42a9-91eb-6372909ab4f5RxCUI 1099687UNII 614OI1Z5WIUPC 0362559266161
- 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
N462559026616followed by a unit qualifier and the quantityPackage 62559-0266-16. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Valproic acid oral solution is 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 oral solution 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 oral solution 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 w…
Excerpt only. Read the full label for complete information.
About NDC 62559-266
- What is NDC 62559-266?
- 62559-266 is the product NDC for Valproic Acid, Valproic acid 250 mg/5mL solution, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valproic Acid.
- What is the active ingredient?
- Valproic acid.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 62559. 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 Acid?
- 27 other product NDCs are listed under this name. See all Valproic Acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valproic Acid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | American Health Packaging | 60687-942 | 60687-0942-1760687-0942-77 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | American Health Packaging | 60687-953 | 60687-0953-56 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-7620 | 00904-7620-7000904-7620-94 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | Major Pharmaceuticals | 0904-7621 | 00904-7621-72 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | REMEDYREPACK INC. | 70518-4298 | 70518-4298-0070518-4298-0270518-4298-04 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | NorthStar Rx LLC | 72603-253 | 72603-0253-01 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | QUAGEN PHARMACEUTICALS LLC | 70752-202 | 70752-0202-12 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | Kesin Pharma Corporation | 81033-266 | 81033-0266-5081033-0266-52 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | REMEDYREPACK INC. | 70518-3805 | 70518-3805-0070518-3805-02 |
| Valproic Acid | Valproic acid 250 mg/1 | CapsuleOral | Direct_Rx | 72189-010 | 72189-0010-30 |
Other NDCs under ANDA 073178
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/5mL | SolutionOral | REMEDYREPACK INC. | 70518-4298 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | NorthStar Rx LLC | 72603-253 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | Kesin Pharma Corporation | 81033-266 |