NDC 0187-0658

Diastat

Diazepam

Diastat is a Rectal Gel in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Diazepam.

• Product ID: 0187-0658_1e7e58ee-24d8-4c34-8e85-7f3a8b425e01
• NDC: 0187-0658
• Product Type: Human Prescription Drug
• Proprietary Name: Diastat
• Generic Name: Diazepam
• Dosage Form: Gel
• Route of Administration: RECTAL
• Marketing Start Date: 1997-07-29
• Marketing Category: NDA / NDA
• Application Number: NDA020648
• Labeler Name: Bausch Health US, LLC
• Substance Name: DIAZEPAM
• Active Ingredient Strength: 10 mg/2mL
• Pharm Classes: Benzodiazepine [EPC], Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0187-0658-20

2 SYRINGE, PLASTIC in 1 PACKAGE (0187-0658-20) > 2 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 1997-07-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-0658-20 [00187065820]

Diastat GEL

• Marketing Category: NDA
• Application Number: NDA020648
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-07-29

Drug Details

Active Ingredients

Ingredient	Strength
DIAZEPAM	10 mg/2mL

OpenFDA Data

• SPL SET ID: a84a73a7-8e3a-4985-8be0-04b3028f5e49
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • Q3JTX2Q7TU
• RxNorm Concept Unique ID - RxCUI:
  • 801966
  • 801965
  • 801962
  • 801961

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]

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

NDC	Brand Name	Generic Name
0187-0658	Diastat	diazepam
0187-0659	Diastat	diazepam
66490-650	Diastat	Diastat
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
0140-0004	Valium	diazepam
0140-0005	Valium	diazepam
0140-0006	Valium	diazepam