NDC 0904-6839

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 ID0904-6839_97a1dba8-d8ff-3e7d-e053-2a95a90aa4c5
NDC0904-6839
Product TypeHuman Otc Drug
Proprietary NameMagnesium Hydroxide/Aluminum Hydroxice/Simethicone
Generic NameMagnesium Hydroxide,aluminum Hydroxice,simethicone
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2019-12-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart331
Labeler NameMajor Pharmaceuticals
Substance NameDIMETHICONE; ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE
Active Ingredient Strength240 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6839-73

10 TRAY in 1 CASE (0904-6839-73) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2019-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6839-73 [00904683973]

Magnesium Hydroxide/Aluminum Hydroxice/Simethicone SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart331
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-12-27

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE240 mg/30mL

OpenFDA Data

SPL SET ID:97978a75-bf85-ba66-e053-2995a90a3b2d
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0904-6838Magnesium Hydroxide/Aluminum Hydroxice/SimethiconeMagnesium Hydroxide/Aluminum Hydroxice/Simethicone
    0904-6839Magnesium Hydroxide/Aluminum Hydroxice/SimethiconeMagnesium Hydroxide,Aluminum Hydroxice,Simethicone
    55154-3557Magnesium Hydroxide/Aluminum Hydroxice/SimethiconeMagnesium Hydroxide,Aluminum Hydroxice,Simethicone

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