NDC 62756-377

Omeprazole

Omeprazole

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

Product ID62756-377_052822e1-7b30-45e4-953e-43996486644a
NDC62756-377
Product TypeHuman Otc Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA207891
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 62756-377-11

2 BOTTLE in 1 CARTON (62756-377-11) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-377-12 [62756037712]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207891
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

NDC 62756-377-96 [62756037796]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207891
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

NDC 62756-377-11 [62756037711]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207891
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

NDC 62756-377-79 [62756037779]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207891
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

NDC 62756-377-70 [62756037770]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207891
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

NDC 62756-377-21 [62756037721]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207891
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:51c3ef34-b7c1-419e-a784-ae82540c7a22
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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