NDC 0140-0005

Valium

Diazepam

Valium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Roche Laboratories Inc.. The primary component is Diazepam.

• Product ID: 0140-0005_5da13043-2476-406e-8658-834dfdb39530
• NDC: 0140-0005
• Product Type: Human Prescription Drug
• Proprietary Name: Valium
• Generic Name: Diazepam
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1963-11-15
• Marketing Category: NDA / NDA
• Application Number: NDA013263
• Labeler Name: Roche Laboratories Inc.
• Substance Name: DIAZEPAM
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Benzodiazepine [EPC], Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0140-0005-01

1 BOTTLE, PLASTIC in 1 CARTON (0140-0005-01) > 100 TABLET in 1 BOTTLE, PLASTIC

• Marketing Start Date: 1963-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0140-0005-14 [00140000514]

Valium TABLET

• Marketing Category: NDA
• Application Number: NDA013263
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1963-11-15

NDC 0140-0005-01 [00140000501]

Valium TABLET

• Marketing Category: NDA
• Application Number: NDA013263
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1963-11-15

Drug Details

Active Ingredients

Ingredient	Strength
DIAZEPAM	5 mg/1

OpenFDA Data

• SPL SET ID: 554baee5-b171-4452-a50a-41a0946f956c
• Manufacturer:
  • Roche Laboratories Inc.
• UNII:
  • Q3JTX2Q7TU
• RxNorm Concept Unique ID - RxCUI:
  • 104700
  • 104701
  • 197589
  • 197591
  • 197590
  • 104699

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]

NDC Crossover Matching brand name "Valium" or generic name "Diazepam"

NDC	Brand Name	Generic Name
0140-0004	Valium	diazepam
0140-0005	Valium	diazepam
0140-0006	Valium	diazepam
55289-117	Valium	Valium
65084-313	Valium	Valium
65084-312	Valium	Valium
80425-0120	Valium	Valium
0187-0658	Diastat	diazepam
0187-0659	Diastat	diazepam
0054-3188	Diazepam	Diazepam
0093-6137	Diazepam	Diazepam
0093-6138	Diazepam	Diazepam
0093-6139	Diazepam	Diazepam
0121-0905	Diazepam	Diazepam
0172-3925	Diazepam	Diazepam
0172-3926	Diazepam	Diazepam
0172-3927	Diazepam	Diazepam