NDC 0536-0091

Aluminum Hydroxide

Aluminum Hydroxide

Aluminum Hydroxide is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Aluminum Hydroxide.

Product ID0536-0091_5e0c3967-d2b0-4acb-e053-2a91aa0af2bf
NDC0536-0091
Product TypeHuman Otc Drug
Proprietary NameAluminum Hydroxide
Generic NameAluminum Hydroxide
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2005-02-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart331
Labeler NameRugby Laboratories
Substance NameALUMINUM HYDROXIDE
Active Ingredient Strength320 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0536-0091-85

473 mL in 1 BOTTLE (0536-0091-85)
Marketing Start Date2017-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-0091-85 [00536009185]

Aluminum Hydroxide LIQUID
Marketing CategoryOTC monograph final
Application Numberpart331
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-07-01

Drug Details

Active Ingredients

IngredientStrength
ALUMINUM HYDROXIDE320 mg/5mL

OpenFDA Data

SPL SET ID:27c574a5-1fe0-4973-9a31-9beb4fc6ec46
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308078
  • UPC Code
  • 0305360091850
  • NDC Crossover Matching brand name "Aluminum Hydroxide" or generic name "Aluminum Hydroxide"

    NDCBrand NameGeneric Name
    0536-0091Aluminum Hydroxidealuminum hydroxide
    17856-0091Aluminum Hydroxidealuminum hydroxide
    24451-091Aluminum HydroxideAluminum Hydroxide
    54162-221DermadroxAluminum Hydroxide

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.