Prescription drug · NDA
Valium (Diazepam) NDC 80725-006
Diazepam 10 mg/1 · Tablet · Oral · Waylis Therapuetics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-006-01 | 80725000601 | 100 TABLET in 1 BOTTLE (80725-006-01)Marketed from Apr 4, 2022 |
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)
- Valium
- Generic name (nonproprietary)
- diazepam
- Active ingredients
- Diazepam — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Waylis Therapuetics LLCNDC labeler code 80725
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 013263
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 80725-006_162faa32-b6de-4c5d-a971-c908c9a951d2SPL ID 162faa32-b6de-4c5d-a971-c908c9a951d2SPL set ID 260e2041-2bb3-482f-850e-b5d47a7bdbe6RxCUI 104699, 104700, 104701, 197589, 197590, 197591UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480725000601followed by a unit qualifier and the quantityPackage 80725-0006-01. 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 Valium is indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Valium is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man…
Excerpt only. Read the full label for complete information.
About NDC 80725-006
- What is NDC 80725-006?
- 80725-006 is the product NDC for Valium (diazepam), Diazepam 10 mg/1 tablet, listed with the FDA by Waylis Therapuetics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valium (Diazepam).
- What is the active ingredient?
- Diazepam.
- Who is the labeler?
- Waylis Therapuetics LLC, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valium?
- 4 other product NDCs are listed under this name. See all Valium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valiumdiazepam | Diazepam 2 mg/1 | TabletOral | Waylis Therapuetics LLC | 80725-004 | 80725-0004-01 |
| Valiumdiazepam | Diazepam 5 mg/1 | TabletOral | Waylis Therapuetics LLC | 80725-005 | 80725-0005-01 |
| Valiumdiazepam | Diazepam 2 mg/1 | TabletOral | Roche Laboratories Inc. | 0140-0004 | 00140-0004-01 |
| Valiumdiazepam | Diazepam 5 mg/1 | TabletOral | Roche Laboratories Inc. | 0140-0005 | 00140-0005-0100140-0005-14 |
Other NDCs under NDA 013263
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 |
|---|---|---|---|---|
| Valiumdiazepam | Diazepam 2 mg/1 | TabletOral | Waylis Therapuetics LLC | 80725-004 |
| Valiumdiazepam | Diazepam 5 mg/1 | TabletOral | Waylis Therapuetics LLC | 80725-005 |
| Valiumdiazepam | Diazepam 2 mg/1 | TabletOral | Roche Laboratories Inc. | 0140-0004 |
| Valiumdiazepam | Diazepam 5 mg/1 | TabletOral | Roche Laboratories Inc. | 0140-0005 |