NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9785Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9785Add 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
0143-9785-10001439785100014397851010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9785-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9785-01)Marketed from Feb 17, 2010

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)
Valproate Sodium
Generic name (nonproprietary)
valproate sodium
Active ingredients
Valproate sodium — 500 mg/5mL
Dosage form
Injection
Route
Intravenous
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078523
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 0143-9785_0610e50d-6447-4a0e-bc36-dc0bffa95c7dSPL ID 0610e50d-6447-4a0e-bc36-dc0bffa95c7dSPL set ID bcf57b31-4811-4104-82b3-46fb91a53ee0RxCUI 1099648UNII 5VOM6GYJ0D
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

N400143978510 followed by a unit qualifier and the quantity

Package 00143-9785-10. 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)

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 wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9785

What is NDC 0143-9785?
0143-9785 is the product NDC for Valproate Sodium, Valproate sodium 500 mg/5mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Valproate SodiumValproate sodium 100 mg/mLInjection, SolutionIntravenousSagent Pharmaceuticals25021-79725021-0797-05
Valproate SodiumValproate sodium 100 mg/mLInjectionIntravenousHikma Pharmaceuticals USA Inc.0143-963700143-9637-10
Valproate SodiumValproate sodium 100 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC63323-49463323-0494-05

Other NDCs under ANDA 078523

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

FDA NDC Directory listings under ANDA 078523
ProductStrengthForm · routeLabelerProduct NDC
Valproate SodiumValproate sodium 100 mg/mLInjectionIntravenousHikma Pharmaceuticals USA Inc.0143-9637

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