Prescription drug · ANDA
Valproate Sodium NDC 0143-9637
Valproate sodium 100 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9637-10 | 00143963710 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01)Marketed from Apr 15, 2013 |
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 — 100 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- 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 0143-9637_4b1e2230-e7d4-470f-9ec5-99d03e80e897SPL ID 4b1e2230-e7d4-470f-9ec5-99d03e80e897SPL set ID 7a687b2f-246d-4736-a20c-92421c263268RxCUI 1099648UNII 5VOM6GYJ0DUPC 0301439637103
- 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
N400143963710followed by a unit qualifier and the quantityPackage 00143-9637-10. 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.
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 500 mg/5mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9785 |