Prescription drug · NDA AUTHORIZED GENERIC
Diazepam NDC 68682-655
Diazepam 20 mg/4mL · Gel · Rectal · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-655-20 | 68682065520 | 2 SYRINGE, PLASTIC in 1 PACKAGE (68682-655-20) / 4 mL in 1 SYRINGE, PLASTICMarketed from Jul 29, 1997 |
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)
- Diazepam
- Generic name (nonproprietary)
- diazepam
- Active ingredients
- Diazepam — 20 mg/4mL
- Dosage form
- Gel
- Route
- Rectal
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020648
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 68682-655_0e23d654-d8b9-af1c-e063-6294a90a6f14SPL ID 0e23d654-d8b9-af1c-e063-6294a90a6f14SPL set ID b1b2848b-b265-4f6f-9141-bf106dec0726RxCUI 801957, 801961, 801966UNII 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 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.
- NDC on a medical claim
N468682065520followed by a unit qualifier and the quantityPackage 68682-0655-20. 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)
INDICATIONS AND USAGE Diazepam rectal gel is intended 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.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020648
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.