NDC 50383-050

Cimetidine Hydrochloride Oral Solution

Cimetidine Hydrochloride Oral Solution

Cimetidine Hydrochloride Oral Solution is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Akorn Operating Company Llc. The primary component is Cimetidine Hydrochloride.

Product ID50383-050_283fc6ae-681a-419b-b155-dab73acf4403
NDC50383-050
Product TypeHuman Prescription Drug
Proprietary NameCimetidine Hydrochloride Oral Solution
Generic NameCimetidine Hydrochloride Oral Solution
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1997-10-28
Marketing CategoryANDA / ANDA
Application NumberANDA074664
Labeler NameAkorn Operating Company LLC
Substance NameCIMETIDINE HYDROCHLORIDE
Active Ingredient Strength300 mg/5mL
Pharm ClassesHistamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50383-050-08

237 mL in 1 BOTTLE (50383-050-08)
Marketing Start Date1997-10-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-050-08 [50383005008]

Cimetidine Hydrochloride Oral Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA074664
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-10-28

Drug Details

Active Ingredients

IngredientStrength
CIMETIDINE HYDROCHLORIDE300 mg/5mL

OpenFDA Data

SPL SET ID:f2ec923a-2b88-43c0-ac2a-7ae20c053039
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 212787
  • Pharmacological Class

    • Histamine H2 Receptor Antagonists [MoA]
    • Histamine-2 Receptor Antagonist [EPC]
    • Histamine H2 Receptor Antagonists [MoA]
    • Histamine-2 Receptor Antagonist [EPC]

    Medicade Reported Pricing

    50383005008 CIMETIDINE 300 MG/5 ML SOLN

    Pricing Unit: ML | Drug Type:

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