Prescription drug · ANDA
Valproic Acid NDC 70518-3805
Valproic acid 250 mg/5mL · Solution · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3805-0 | 70518380500 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3805-0) / 5 mL in 1 CUP, UNIT-DOSE (70518-3805-1)Marketed from Jul 25, 2023 | |
| 70518-3805-2 | 70518380502 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3805-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-3805-3)Marketed from Mar 13, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075379
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 70518-3805_53bf570a-deeb-ede3-e063-6294a90ad4dcSPL ID 53bf570a-deeb-ede3-e063-6294a90ad4dcSPL set ID 65c1589e-c591-4b79-b75e-884c0d609ae8RxCUI 1099687UNII 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
N470518380500followed by a unit qualifier and the quantityPackage 70518-3805-00. 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 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 seizures. Simple absenc…
Excerpt only. Read the full label for complete information.
About NDC 70518-3805
- What is NDC 70518-3805?
- 70518-3805 is the product NDC for Valproic Acid, Valproic acid 250 mg/5mL solution, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | ANI Pharmaceuticals, Inc. | 62559-266 | 62559-0266-16 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | Kesin Pharma Corporation | 81033-266 | 81033-0266-5081033-0266-52 |
| Valproic Acid | Valproic acid 250 mg/1 | CapsuleOral | Direct_Rx | 72189-010 | 72189-0010-30 |
Other NDCs under ANDA 075379
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 | Major Pharmaceuticals | 0904-7620 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | Major Pharmaceuticals | 0904-7621 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0675 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | American Health Packaging | 60687-942 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | American Health Packaging | 60687-953 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4675 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1350 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | Bryant Ranch Prepack | 71335-2250 |