Prescription drug · ANDA
Valproate Sodium NDC 0143-9785
Valproate sodium 500 mg/5mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9785-10 | 0014397851000143978510 | 10 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.
- NDC on a medical claim
N400143978510followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Valproate Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 100 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-494 | 63323-0494-05 |
Other NDCs under ANDA 078523
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Valproate Sodium | Valproate sodium 100 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9637 |