Prescription drug · NDA
Valium (Diazepam) NDC 0140-0005
Diazepam 5 mg/1 · Tablet · Oral · Roche Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0140-0005-01 | 0014000050100140000501 | 1 BOTTLE, PLASTIC in 1 CARTON (0140-0005-01) / 100 TABLET in 1 BOTTLE, PLASTICMarketed from Nov 15, 1963 | |
| 0140-0005-14 | 0014000051400140000514 | 1 BOTTLE, PLASTIC in 1 CARTON (0140-0005-14) / 500 TABLET in 1 BOTTLE, PLASTICMarketed from Nov 15, 1963 |
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)
- Valium
- Generic name (nonproprietary)
- diazepam
- Active ingredients
- Diazepam — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Roche Laboratories Inc.NDC labeler code 0140
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 013263
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0140-0005_ea505cdb-6d89-4b8c-8007-ec5a5fe920ceSPL ID ea505cdb-6d89-4b8c-8007-ec5a5fe920ceSPL set ID 554baee5-b171-4452-a50a-41a0946f956cRxCUI 104699, 104700, 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
N400140000501followed by a unit qualifier and the quantityPackage 00140-0005-01. 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 0140-0005
- What is NDC 0140-0005?
- 0140-0005 is the product NDC for Valium (diazepam), Diazepam 5 mg/1 tablet, listed with the FDA by Roche Laboratories Inc.. It has 2 package NDCs, 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?
- Roche Laboratories Inc., NDC labeler code 0140. 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 Therapeutics LLC | 80725-004 | 80725-0004-01 |
| Valiumdiazepam | Diazepam 5 mg/1 | TabletOral | Waylis Therapeutics LLC | 80725-005 | 80725-0005-01 |
| Valiumdiazepam | Diazepam 10 mg/1 | TabletOral | Waylis Therapeutics LLC | 80725-006 | 80725-0006-01 |
| Valiumdiazepam | Diazepam 2 mg/1 | TabletOral | Roche Laboratories Inc. | 0140-0004 | 00140-0004-01 |
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 | Roche Laboratories Inc. | 0140-0004 |
| Valiumdiazepam | Diazepam 2 mg/1 | TabletOral | Waylis Therapeutics LLC | 80725-004 |
| Valiumdiazepam | Diazepam 5 mg/1 | TabletOral | Waylis Therapeutics LLC | 80725-005 |
| Valiumdiazepam | Diazepam 10 mg/1 | TabletOral | Waylis Therapeutics LLC | 80725-006 |