NDC 43598-286

Omeprazole

Omeprazole

Omeprazole is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Dr. Reddys Laboratories Inc. The primary component is Omeprazole.

Product ID43598-286_1860513f-b27e-f999-9789-ffebd454fb89
NDC43598-286
Product TypeHuman Otc Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-11-06
Marketing CategoryANDA / ANDA
Application NumberANDA207740
Labeler NameDr. Reddys Laboratories Inc
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43598-286-25

2 BLISTER PACK in 1 CARTON (43598-286-25) > 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43598-286-70 [43598028670]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-06

NDC 43598-286-33 [43598028633]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-06

NDC 43598-286-52 [43598028652]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-06

NDC 43598-286-32 [43598028632]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-06

NDC 43598-286-37 [43598028637]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-06

NDC 43598-286-74 [43598028674]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-06

NDC 43598-286-25 [43598028625]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-06

NDC 43598-286-27 [43598028627]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-06

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:4b3b389d-a151-d851-cb05-64eb49979e5e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402014
  • NDC Crossover Matching brand name "Omeprazole" or generic name "Omeprazole"

    NDCBrand NameGeneric Name
    0093-5294OmeprazoleOmeprazole
    0363-0007omeprazoleOmeprazole
    0363-0915omeprazoleOmeprazole
    0363-1607OmeprazoleOmeprazole
    0363-1819omeprazoleomeprazole
    0363-9980OmeprazoleOMEPRAZOLE MAGNESIUM
    0378-5211Omeprazoleomeprazole
    0378-5222Omeprazoleomeprazole
    0378-6150Omeprazoleomeprazole
    0615-1359OmeprazoleOmeprazole
    0615-2302OmeprazoleOmeprazole
    0615-2305OmeprazoleOmeprazole
    0615-7933OmeprazoleOmeprazole
    0615-8079OmeprazoleOmeprazole
    0615-8320OmeprazoleOmeprazole
    0615-8406OmeprazoleOmeprazole
    0781-2234OmeprazoleOmeprazole
    68016-759OmeprazoleOmeprazole
    68071-1522OmeprazoleOmeprazole
    68071-2180OmeprazoleOmeprazole
    68071-1948OmeprazoleOmeprazole
    68071-3285OmeprazoleOmeprazole
    68071-3007OmeprazoleOmeprazole
    68071-2199OmeprazoleOmeprazole
    68071-4051OmeprazoleOmeprazole
    68071-3368OmeprazoleOmeprazole
    68071-4140OmeprazoleOmeprazole
    68071-4146OmeprazoleOmeprazole
    68071-4024OmeprazoleOmeprazole
    68071-4025OmeprazoleOmeprazole
    68084-466OmeprazoleOmeprazole
    68084-128OmeprazoleOmeprazole
    68151-3088OmeprazoleOmeprazole
    68382-411OmeprazoleOmeprazole
    68382-412OmeprazoleOmeprazole
    68382-500OmeprazoleOmeprazole
    68462-395OmeprazoleOmeprazole
    68462-396OmeprazoleOmeprazole
    68462-397OmeprazoleOmeprazole
    68788-6881OmeprazoleOmeprazole
    68788-1554OmeprazoleOmeprazole
    68788-9748OmeprazoleOmeprazole
    68788-6995OmeprazoleOmeprazole
    68788-9955OmeprazoleOmeprazole
    69181-158OmeprazoleOmeprazole
    69189-0147OmeprazoleOmeprazole
    69677-180OmeprazoleOmeprazole
    69618-047OmeprazoleOmeprazole
    69842-791OmeprazoleOmeprazole
    70518-0056OmeprazoleOmeprazole

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