Valium (diazepam) NDC 80725-004

NDC codes

FDA NDC Directory

Product NDC (as listed)80725-004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80725-0004Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
80725-004-01	80725000401	100 TABLET in 1 BOTTLE (80725-004-01)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 — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Waylis Therapuetics LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 013263
Marketing start: Apr 4, 2022
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 80725-004_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

N480725000401 followed by a unit qualifier and the quantity

Package 80725-0004-01. 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 Aug 11, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 013263

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 013263
Product	Strength	Form · route	Labeler	Product NDC
Valiumdiazepam	Diazepam 10 mg/1	TabletOral	Waylis Therapuetics LLC	80725-006
Valiumdiazepam	Diazepam 5 mg/1	TabletOral	Waylis Therapuetics LLC	80725-005
Valiumdiazepam	Diazepam 5 mg/1	TabletOral	Roche Laboratories Inc.	0140-0005
Valiumdiazepam	Diazepam 2 mg/1	TabletOral	Roche Laboratories Inc.	0140-0004