Prescription drug · NDA
Valtoco (diazepam) NDC 72252-515
Diazepam 7.5 mg/.1mL · Spray · Nasal · Neurelis, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72252-515-04 | 72252051504 | 2 BLISTER PACK in 1 CARTON (72252-515-04) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 10, 2020 | |
| 72252-515-10 | 72252051510 | 5 BLISTER PACK in 1 CARTON (72252-515-10) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 28, 2025 |
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)
- Valtoco
- Generic name (nonproprietary)
- diazepam
- Active ingredients
- Diazepam — 7.5 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Neurelis, Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211635
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 72252-515_6642d0cb-3186-4b4c-8a67-c3f92081fbd0SPL ID 6642d0cb-3186-4b4c-8a67-c3f92081fbd0SPL set ID 1a8bcc90-68fa-474d-832c-0df01e825f39RxCUI 2272613, 2272619, 2272621, 2272622, 2272623, 2272624, 2272626, 2272627, 2272629, 2272630, 2272632, 2272633, 2272635, 2272636UNII Q3JTX2Q7TU
- Pharmacologic class
- Benzodiazepine
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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472252051504followed by a unit qualifier and the quantityPackage 72252-0515-04. 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)
VALTOCO ® is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older. VALTOCO is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 211635
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.