NDC 55289-117

Valium

Diazepam

Valium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Diazepam.

• Product ID: 55289-117_655a3c65-33e4-1681-e053-2991aa0a3549
• NDC: 55289-117
• 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: PD-Rx Pharmaceuticals, 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: 2019-12-31

Packaging

NDC 55289-117-12

12 TABLET in 1 BOTTLE, PLASTIC (55289-117-12)

• Marketing Start Date: 2010-04-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-117-20 [55289011720]

Valium TABLET

• Marketing Category: NDA
• Application Number: NDA013263
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-02
• Marketing End Date: 2019-09-11

NDC 55289-117-12 [55289011712]

Valium TABLET

• Marketing Category: NDA
• Application Number: NDA013263
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-02
• Marketing End Date: 2019-09-11

NDC 55289-117-06 [55289011706]

Valium TABLET

• Marketing Category: NDA
• Application Number: NDA013263
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-02
• Marketing End Date: 2019-09-11

Drug Details

Active Ingredients

Ingredient	Strength
DIAZEPAM	5 mg/1

OpenFDA Data

• SPL SET ID: b47a0a1f-800c-46bd-905d-0b10858aa5f1
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • Q3JTX2Q7TU
• RxNorm Concept Unique ID - RxCUI:
  • 197591
  • 104700
• UPC Code:
  • 0355289117209

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