Prescription drug · ANDA
Valproic Acid NDC 0116-4021
Valproic acid 250 mg/5mL · Solution · Oral · Xttrium Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-4021-11 | 0011640211100116402111 | 10 TRAY in 1 CASE (0116-4021-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4021-10)Marketed from Jul 29, 2025 | |
| 0116-4021-16 | 0011640211600116402116 | 473 mL in 1 BOTTLE, PLASTIC (0116-4021-16)Marketed from Jul 29, 2025 | |
| 0116-4021-40 | 0011640214000116402140 | 4 TRAY in 1 CASE (0116-4021-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05)Marketed from Jul 29, 2025 | |
| 0116-4021-41 | 0011640214100116402141 | 10 TRAY in 1 CASE (0116-4021-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05)Marketed from Jul 29, 2025 |
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/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Xttrium Laboratories Inc.NDC labeler code 0116
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070868
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0116-4021_4459a233-1fe1-41dc-e063-6394a90a5ab4SPL ID 4459a233-1fe1-41dc-e063-6394a90a5ab4SPL set ID 3b124a29-30bd-d30e-e063-6294a90ac4caRxCUI 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
N400116402111followed by a unit qualifier and the quantityPackage 00116-4021-11. 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)
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 absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and…
Excerpt only. Read the full label for complete information.
About NDC 0116-4021
- What is NDC 0116-4021?
- 0116-4021 is the product NDC for Valproic Acid, Valproic acid 250 mg/5mL solution, listed with the FDA by Xttrium Laboratories Inc.. It has 4 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?
- Xttrium Laboratories Inc., NDC labeler code 0116. 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 |