What is NDC 63323-494?

63323-494 is the product NDC for Valproate Sodium, Valproate sodium 100 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Valproate Sodium?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valproate Sodium NDC 63323-494 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-494Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0494Add 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 NDC	11-digit (billing)	Package	Copy
63323-494-16	63323049416	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-16) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41)Marketed from Aug 18, 2003

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): Valproate Sodium
Generic name (nonproprietary): valproate sodium
Active ingredients: Valproate sodium — 100 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076539
Marketing start: Aug 18, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 63323-494_f09a2148-edd9-4918-8359-7554ed263d3aSPL ID f09a2148-edd9-4918-8359-7554ed263d3aSPL set ID 3dfb6da1-f66a-4618-9f74-d2d6c16c0b58RxCUI 1099648UNII 5VOM6GYJ0DUPC 0363323494414
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323049416 followed by a unit qualifier and the quantity

Package 63323-0494-16. 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 Dec 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Valproate sodium injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1 ) 1.1 Epilepsy Valproate sodium injection is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible in the following conditions: Valproate sodium injection is indicated as monotherapy and adjunctive therapy in the treatment of patients …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-494

What is NDC 63323-494?: 63323-494 is the product NDC for Valproate Sodium, Valproate sodium 100 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Valproate Sodium.
What is the active ingredient?: Valproate sodium.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Valproate Sodium?: 3 other product NDCs are listed under this name. See all Valproate Sodium 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 Valproate Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Valproate Sodium	Valproate sodium 100 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-797	25021-0797-05
Valproate Sodium	Valproate sodium 100 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9637	00143-9637-10
Valproate Sodium	Valproate sodium 500 mg/5mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9785	00143-9785-10