NDC 69618-047

Omeprazole

Omeprazole

Omeprazole is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Reliable 1 Laboratories Llc. The primary component is Omeprazole Magnesium.

Product ID69618-047_7cc2e12a-ea77-28c9-e053-2991aa0ad3a7
NDC69618-047
Product TypeHuman Otc Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-08-16
Marketing CategoryANDA / ANDA
Application NumberANDA078878
Labeler NameReliable 1 Laboratories LLC
Substance NameOMEPRAZOLE MAGNESIUM
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69618-047-42

3 BOTTLE, PLASTIC in 1 CARTON (69618-047-42) > 14 CAPSULE in 1 BOTTLE, PLASTIC (69618-047-14)
Marketing Start Date2018-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69618-047-14 [69618004714]

Omeprazole CAPSULE
Marketing CategoryANDA
Application NumberANDA078878
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-08-16

NDC 69618-047-42 [69618004742]

Omeprazole CAPSULE
Marketing CategoryANDA
Application NumberANDA078878
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-08-16

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

OpenFDA Data

SPL SET ID:5bfea5f5-898e-4ddb-e053-2a91aa0af2f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198051
  • 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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