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 ID: 50383-050_283fc6ae-681a-419b-b155-dab73acf4403
• NDC: 50383-050
• Product Type: Human Prescription Drug
• Proprietary Name: Cimetidine Hydrochloride Oral Solution
• Generic Name: Cimetidine Hydrochloride Oral Solution
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1997-10-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074664
• Labeler Name: Akorn Operating Company LLC
• Substance Name: CIMETIDINE HYDROCHLORIDE
• Active Ingredient Strength: 300 mg/5mL
• Pharm Classes: Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50383-050-08

237 mL in 1 BOTTLE (50383-050-08)

• Marketing Start Date: 1997-10-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50383-050-08 [50383005008]

Cimetidine Hydrochloride Oral Solution SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074664
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-10-28

Drug Details

Active Ingredients

Ingredient	Strength
CIMETIDINE HYDROCHLORIDE	300 mg/5mL

OpenFDA Data

• SPL SET ID: f2ec923a-2b88-43c0-ac2a-7ae20c053039
• Manufacturer:
  • Hi-Tech Pharmacal Co., Inc.
• UNII:
  • WF10491673
• 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: