Prescription drug · ANDA

Valproic Acid NDC 81033-266

Valproic acid 250 mg/5mL · Solution · Oral · Kesin Pharma Corporation

NDC codes

FDA NDC Directory
Product NDC (as listed)81033-266Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81033-0266Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
81033-266-5081033026650100 CUP, UNIT-DOSE in 1 CASE (81033-266-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-266-05)Marketed from Aug 1, 2025
81033-266-5281033026652100 CUP, UNIT-DOSE in 1 CASE (81033-266-52) / 10 mL in 1 CUP, UNIT-DOSE (81033-266-10)Marketed from Aug 1, 2025

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
Kesin Pharma CorporationNDC labeler code 81033
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 81033-266_3a214bf4-ea91-0892-e063-6394a90a9a9dSPL ID 3a214bf4-ea91-0892-e063-6394a90a9a9dSPL set ID 3a2155d0-e79d-3e11-e063-6294a90a4aaeRxCUI 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

N481033026650 followed by a unit qualifier and the quantity

Package 81033-0266-50. 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 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 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 al…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81033-266

What is NDC 81033-266?
81033-266 is the product NDC for Valproic Acid, Valproic acid 250 mg/5mL solution, listed with the FDA by Kesin Pharma Corporation. 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?
Kesin Pharma Corporation, NDC labeler code 81033. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Valproic Acid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Valproic AcidValproic acid 250 mg/5mLSolutionOralAmerican Health Packaging60687-94260687-0942-1760687-0942-77
Valproic AcidValproic acid 500 mg/10mLSolutionOralAmerican Health Packaging60687-95360687-0953-56
Valproic AcidValproic acid 250 mg/5mLSolutionOralMajor Pharmaceuticals0904-762000904-7620-7000904-7620-94
Valproic AcidValproic acid 500 mg/10mLSolutionOralMajor Pharmaceuticals0904-762100904-7621-72
Valproic AcidValproic acid 250 mg/5mLSolutionOralREMEDYREPACK INC.70518-429870518-4298-0070518-4298-0270518-4298-04
Valproic AcidValproic acid 250 mg/5mLSolutionOralNorthStar Rx LLC72603-25372603-0253-01
Valproic AcidValproic acid 250 mg/5mLSolutionOralQUAGEN PHARMACEUTICALS LLC70752-20270752-0202-12
Valproic AcidValproic acid 250 mg/5mLSolutionOralANI Pharmaceuticals, Inc.62559-26662559-0266-16
Valproic AcidValproic acid 250 mg/5mLSolutionOralREMEDYREPACK INC.70518-380570518-3805-0070518-3805-02
Valproic AcidValproic acid 250 mg/1CapsuleOralDirect_Rx72189-01072189-0010-30

All 28 Valproic Acid NDCs

Other NDCs under ANDA 073178

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 073178
ProductStrengthForm · routeLabelerProduct NDC
Valproic AcidValproic acid 250 mg/5mLSolutionOralREMEDYREPACK INC.70518-4298
Valproic AcidValproic acid 250 mg/5mLSolutionOralNorthStar Rx LLC72603-253
Valproic AcidValproic acid 250 mg/5mLSolutionOralANI Pharmaceuticals, Inc.62559-266

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