NDC codes

FDA NDC Directory
Product NDC (as listed)62559-266Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0266Add 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
62559-266-1662559026616473 mL in 1 BOTTLE (62559-266-16)Marketed from Jan 2, 2024

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
ANI Pharmaceuticals, Inc.NDC labeler code 62559
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 62559-266_36e8a44c-2c80-4c44-8cad-9ea6de9807c3SPL ID 36e8a44c-2c80-4c44-8cad-9ea6de9807c3SPL set ID 2314af65-b928-42a9-91eb-6372909ab4f5RxCUI 1099687UNII 614OI1Z5WIUPC 0362559266161
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

N462559026616 followed by a unit qualifier and the quantity

Package 62559-0266-16. 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 oral solution 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 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 w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-266

What is NDC 62559-266?
62559-266 is the product NDC for Valproic Acid, Valproic acid 250 mg/5mL solution, listed with the FDA by ANI Pharmaceuticals, Inc.. 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?
ANI Pharmaceuticals, Inc., NDC labeler code 62559. 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/5mLSolutionOralKesin Pharma Corporation81033-26681033-0266-5081033-0266-52
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/5mLSolutionOralKesin Pharma Corporation81033-266

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