NDC codes

FDA NDC Directory
Product NDC (as listed)62135-196Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0196Add 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
62135-196-24621350196242 TRAY in 1 BOX (62135-196-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45)Marketed from May 28, 2024
62135-196-4762135019647473 mL in 1 BOTTLE (62135-196-47)Marketed from Aug 15, 2022

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 acid250 mg/5mL
Dosage form
Solution
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075782
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 62135-196_5071bcb9-2d2f-24e3-e063-6294a90a8e56SPL ID 5071bcb9-2d2f-24e3-e063-6294a90a8e56SPL set ID 8051ad62-3b6e-461e-8090-60f5c0a904f4RxCUI 1099687UNII 614OI1Z5WIUPC 0362135196479
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

N462135019624 followed by a unit qualifier and the quantity

Package 62135-0196-24. 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 whi

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075782

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

FDA NDC Directory listings under ANDA 075782
ProductStrengthForm · routeLabelerProduct NDC
Valproic AcidValproic acid 500 mg/10mLSolutionOralChartwell RX, LLC62135-874
Valproic AcidValproic acid 250 mg/5mLSolutionOralChartwell Governmental & Specialty RX, LLC.68999-196
Valproic AcidValproic acid 500 mg/10mLSolutionOralChartwell Governmental & Specialty RX, LLC.68999-874

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