Prescription drug · ANDA
Valproic Acid NDC 72189-010
Valproic acid 250 mg/1 · Capsule · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-010-30 | 72189001030 | 30 CAPSULE in 1 BOTTLE (72189-010-30)Marketed from Jun 21, 2019 |
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/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- 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 72189-010_2c290b36-b0f4-2265-e063-6394a90af311SPL ID 2c290b36-b0f4-2265-e063-6394a90af311SPL set ID 8bdbacb1-b38a-3282-e053-2a95a90af022RxCUI 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
N472189001030followed by a unit qualifier and the quantityPackage 72189-0010-30. 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)
These highlights do not include all the information needed to use VALPROIC ACID CAPSULES safely and effectively. See full prescribing information for VALPROIC ACID CAPSULES. VALPROIC ACID capsules for oral use Initial U.S. Approval: 1978 WARNING: LIFE THREATENING ADVERSE REACTIONS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter (5.1) Fetal Risk, particularly neural tube defects, other maj…
Excerpt only. Read the full label for complete information.
About NDC 72189-010
- What is NDC 72189-010?
- 72189-010 is the product NDC for Valproic Acid, Valproic acid 250 mg/1 capsule, listed with the FDA by Direct_Rx. 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?
- Direct_Rx, NDC labeler code 72189. 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 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 |
|---|---|---|---|---|
| Valproicvalproic acid | Valproic acid 250 mg/1 | Capsule, Liquid filledOral | Actavis Pharma, Inc. | 0591-4012 |
| 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 |