Prescription drug · ANDA
Valproic Acid NDC 0615-8205
Valproic acid 250 mg/1 · Capsule, Liquid filled · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8205-39 | 0061582053900615820539 | 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8205-39)Marketed from Mar 5, 2018 |
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 Acid
- Generic name (nonproprietary)
- valproic acid
- Active ingredients
- Valproic acid — 250 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073484
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0615-8205_1c3c29dc-91bf-4a3a-8b8b-b43ad586e66bSPL ID 1c3c29dc-91bf-4a3a-8b8b-b43ad586e66bSPL set ID 8785a152-3010-4370-aaf5-11315a1a56e1RxCUI 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
N400615820539followed by a unit qualifier and the quantityPackage 00615-8205-39. 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 Capsules are 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 Capsules are 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 Capsules are 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 a…
Excerpt only. Read the full label for complete information.
About NDC 0615-8205
- What is NDC 0615-8205?
- 0615-8205 is the product NDC for Valproic Acid, Valproic acid 250 mg/1 capsule, liquid filled, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. 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?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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/5mL | SolutionOral | REMEDYREPACK INC. | 70518-3805 | 70518-3805-0070518-3805-02 |
Other NDCs under ANDA 073484
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 | Capsule, Liquid filledOral | ATLANTIC BIOLOGICALS CORP. | 17856-0152 |
| Valproic Acid | Valproic acid 250 mg/1 | Capsule, Liquid filledOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-279 |
| Valproic Acid | Valproic acid 250 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 63629-2454 |
| Valproic Acid | Valproic acid 250 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-150 |
| Valproic Acid | Valproic acid 250 mg/1 | Capsule, Liquid filledOral | REMEDYREPACK INC. | 70518-0079 |