Diazepam Intensol (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Diazepam IntensolTM Oral Solution (Concentrate), Class IV

25 mg per 5 mL (5 mg/mL), 30 mL

NDC 0054-3185-44

diazepam-intensol-fc-c50000468-01-k03
(click image for full-size original)

Package/Label Display Panel

Diazepam IntensolTM Oral Solution (Concentrate), Class IV

25 mg per 5 mL (5 mg/mL), 30 mL

NDC 0054-3185-44

diazepam-intensol-os-bl-25mg-5ml
(click image for full-size original)
diazepam-intensol-os-bl-25mg-5ml
DIAZEPAM INTENSOL
diazepam intensol solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-3185
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM (DIAZEPAM) DIAZEPAM 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 190 mg in 1 mL
D&C YELLOW NO. 10
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SUCCINIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-3185-44 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (0054-3185-44)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071415 04/03/1987
Labeler — Hikma Pharmaceuticals USA Inc. (080189610)
Establishment
Name Address ID/FEI Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE (0054-3185)

Revised: 11/2022 Hikma Pharmaceuticals USA Inc.

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