NDC 0904-6838

Magnesium Hydroxide/Aluminum Hydroxice/Simethicone

Magnesium Hydroxide/aluminum Hydroxice/simethicone

Magnesium Hydroxide/Aluminum Hydroxice/Simethicone is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Dimethicone; Aluminum Hydroxide; Magnesium Hydroxide.

• Product ID: 0904-6838_97a1dba8-d8ff-3e7d-e053-2a95a90aa4c5
• NDC: 0904-6838
• Product Type: Human Otc Drug
• Proprietary Name: Magnesium Hydroxide/Aluminum Hydroxice/Simethicone
• Generic Name: Magnesium Hydroxide/aluminum Hydroxice/simethicone
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2019-12-27
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part331
• Labeler Name: Major Pharmaceuticals
• Substance Name: DIMETHICONE; ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE
• Active Ingredient Strength: 120 mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0904-6838-73

10 TRAY in 1 CASE (0904-6838-73) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

• Marketing Start Date: 2019-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-6838-73 [00904683873]

Magnesium Hydroxide/Aluminum Hydroxice/Simethicone SUSPENSION

• Marketing Category: OTC monograph final
• Application Number: part331
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-27

Drug Details

Active Ingredients

Ingredient	Strength
DIMETHICONE	120 mg/30mL

OpenFDA Data

• SPL SET ID: 97978a75-bf85-ba66-e053-2995a90a3b2d
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 5QB0T2IUN0
  • NBZ3QY004S
  • 92RU3N3Y1O
• RxNorm Concept Unique ID - RxCUI:
  • 237870
  • 307746
• UPC Code:
  • 0309046838739
  • 0309046839736

NDC Crossover Matching brand name "Magnesium Hydroxide/Aluminum Hydroxice/Simethicone" or generic name "Magnesium Hydroxide/aluminum Hydroxice/simethicone"

NDC	Brand Name	Generic Name
0904-6838	Magnesium Hydroxide/Aluminum Hydroxice/Simethicone	Magnesium Hydroxide/Aluminum Hydroxice/Simethicone
0904-6839	Magnesium Hydroxide/Aluminum Hydroxice/Simethicone	Magnesium Hydroxide,Aluminum Hydroxice,Simethicone
55154-3557	Magnesium Hydroxide/Aluminum Hydroxice/Simethicone	Magnesium Hydroxide,Aluminum Hydroxice,Simethicone