NDC 52584-081

Midazolam

Midazolam

Midazolam is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Midazolam Hydrochloride.

Product ID52584-081_0e83d70b-3854-4bd2-ad41-8aa9004e0050
NDC52584-081
Product TypeHuman Prescription Drug
Proprietary NameMidazolam
Generic NameMidazolam
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2019-07-09
Marketing CategoryANDA / ANDA
Application NumberANDA075154
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameMIDAZOLAM HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 52584-081-13

1 VIAL in 1 BAG (52584-081-13) > 10 mL in 1 VIAL
Marketing Start Date2019-07-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-081-13 [52584008113]

Midazolam INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075154
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-09

Drug Details

Active Ingredients

IngredientStrength
MIDAZOLAM HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:854da2c9-1c66-42d5-98f4-4013bcdb6bac
Manufacturer
UNII

Pharmacological Class

  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]
  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]

NDC Crossover Matching brand name "Midazolam" or generic name "Midazolam"

NDCBrand NameGeneric Name
0404-9912MidazolamMidazolam
0404-9913MidazolamMidazolam
0404-9914MIDAZOLAMmidazoalm
0404-9915MidazolamMidazolam
0641-6056MidazolamMidazolam
0641-6057MidazolamMidazolam
0641-6059MidazolamMidazolam
0641-6060MidazolamMidazolam
0641-6061MidazolamMidazolam
0641-6063MidazolamMidazolam
0641-6190MidazolamMidazolam
0641-6209MidazolamMidazolam
0641-6210MidazolamMidazolam
0641-6211MidazolamMidazolam
17478-523MidazolamMidazolam Hydrochloride
17478-524MidazolamMidazolam Hydrochloride
47781-588Midazolammidazolam hydrochloride
47781-589Midazolammidazolam hydrochloride
50090-0683MidazolamMidazolam
50090-0738MidazolamMidazolam
50090-3312Midazolammidazolam hydrochloride
50090-3435Midazolammidazolam hydrochloride
70860-601MidazolamMidazolam
70860-600MidazolamMidazolam
76045-003MidazolamMidazolam
76045-001MidazolamMidazolam
76045-002MidazolamMidazolam
51662-1324MIDAZOLAMMIDAZOLAM
51662-1236MIDAZOLAMMIDAZOLAM
51662-1237MIDAZOLAMMIDAZOLAM
52584-596MidazolamMidazolam
52584-055MidazolamMidazolam
52584-056MidazolamMidazolam
52584-059MidazolamMidazolam
52584-589MIDAZOLAMMIDAZOLAM
55154-2889MidazolamMidazolam
63323-411MidazolamMidazolam
63323-412MidazolamMidazolam
65293-412MidazolamMidazolam
65293-414MidazolamMidazolam
65293-416MidazolamMidazolam
65293-415MidazolamMidazolam
65293-411MidazolamMidazolam
65293-413MidazolamMidazolam
65293-417MidazolamMidazolam
52584-081MidazolamMidazolam
50474-500Nayzilammidazolam

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