NDC 55319-037

Acid Reducer

Omeprazole

Acid Reducer is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Family Dollar, Inc.. The primary component is Omeprazole Magnesium.

Product ID55319-037_16e73afd-256e-4a45-9405-be4e0c54c1c2
NDC55319-037
Product TypeHuman Otc Drug
Proprietary NameAcid Reducer
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-06-06
Marketing CategoryANDA / ANDA
Application NumberANDA206877
Labeler NameFamily Dollar, Inc.
Substance NameOMEPRAZOLE MAGNESIUM
Active Ingredient Strength20 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55319-037-05

1 BOTTLE in 1 CARTON (55319-037-05) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2018-06-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55319-037-62 [55319003762]

Acid Reducer TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA206877
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-06

NDC 55319-037-05 [55319003705]

Acid Reducer TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA206877
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-06

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

OpenFDA Data

SPL SET ID:6d8daf78-1672-4bbf-a022-514bf0a5ac9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402014
  • NDC Crossover Matching brand name "Acid Reducer" or generic name "Omeprazole"

    NDCBrand NameGeneric Name
    0363-1008Acid ReducerOmeprazole
    0363-9977Acid ReducerEsomeprazole magnesium
    0536-1322Acid ReducerOmeprazole
    68016-351Acid ReducerAcid Reducer
    69842-871Acid ReducerAcid Reducer
    69842-293Acid ReducerAcid Reducer
    69842-307acid reduceracid reducer
    69842-869Acid ReducerAcid Reducer
    70000-0232Acid ReducerAcid Reducer
    0904-6350Acid ReducerAcid Reducer
    11822-0852Acid ReducerAcid Reducer
    15127-340Acid ReducerAcid Reducer
    21130-003Acid ReducerAcid Reducer
    30142-323Acid ReducerAcid Reducer
    37012-852Acid ReducerAcid Reducer
    37012-950Acid ReducerAcid Reducer
    37808-351Acid ReducerAcid Reducer
    37808-710Acid ReducerAcid Reducer
    37808-507Acid ReducerAcid Reducer
    37835-189Acid ReducerAcid Reducer
    37808-876Acid ReducerAcid Reducer
    41250-876acid reduceracid reducer
    41250-852acid reduceracid reducer
    41250-950acid reduceracid reducer
    49035-983Acid ReducerAcid Reducer
    49035-351Acid ReducerAcid Reducer
    49348-026acid reduceracid reducer
    49781-027Acid ReducerAcid Reducer
    50804-352Acid ReducerAcid Reducer
    51660-352Acid ReducerAcid Reducer
    51660-351Acid ReducerAcid Reducer
    53943-016Acid ReducerAcid Reducer
    55319-037Acid ReducerAcid Reducer
    55315-351Acid ReducerAcid Reducer
    55315-996Acid ReducerAcid Reducer
    56062-141acid reduceracid reducer
    57896-717ACID REDUCERACID REDUCER
    57896-715ACID REDUCERACID REDUCER
    58602-826Acid ReducerAcid Reducer
    58602-729Acid ReducerAcid Reducer
    59726-127Acid ReducerAcid Reducer
    59779-354ACID REDUCERACID REDUCER
    59779-540acid reduceracid reducer
    59779-950acid reduceracid reducer
    61715-089Acid ReducerAcid Reducer
    61715-090Acid ReducerAcid Reducer
    62011-0227acid reduceracid reducer
    63868-487ACID REDUCERACID REDUCER
    63941-006Acid ReducerAcid Reducer
    63941-351ACID REDUCERACID REDUCER

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