NDC 69618-056

Esomeprazole

Esomeprazole

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

Product ID69618-056_7a7b80f1-fd8b-a78f-e053-2991aa0a7098
NDC69618-056
Product TypeHuman Otc Drug
Proprietary NameEsomeprazole
Generic NameEsomeprazole
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA207673
Labeler NameReliable 1 Laboratories
Substance NameESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69618-056-42

3 BOTTLE, PLASTIC in 1 CARTON (69618-056-42) > 14 CAPSULE in 1 BOTTLE, PLASTIC (69618-056-14)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69618-056-14 [69618005614]

Esomeprazole CAPSULE
Marketing CategoryANDA
Application NumberANDA207673
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 69618-056-42 [69618005642]

Esomeprazole CAPSULE
Marketing CategoryANDA
Application NumberANDA207673
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

OpenFDA Data

SPL SET ID:7a7b80f1-fd8a-a78f-e053-2991aa0a7098
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606726

    • NDC Crossover Matching brand name "Esomeprazole" or generic name "Esomeprazole"

    NDCBrand NameGeneric Name
    0591-4187EsomeprazoleEsomeprazole
    30142-989esomeprazoleesomeprazole
    69618-056EsomeprazoleEsomeprazole
    63304-740EsomeprazoleEsomeprazole
    51660-027EsomeprazoleEsomeprazole
    0113-0732basic care esomeprazole magnesiumEsomeprazole
    41163-539equaline esomeprazole magnesiumEsomeprazole
    0363-1699Esomeprazole Magnesiumesomeprazole
    0363-1898esomeprazole magnesiumEsomeprazole
    11822-0024esomeprazole magnesiumesomeprazole
    11822-0898esomeprazole magnesiumEsomeprazole
    30142-273esomeprazole magnesiumesomeprazole
    30142-413esomeprazole magnesiumEsomeprazole
    37012-898esomeprazole magnesiumEsomeprazole
    37808-719Esomeprazole Magnesiumesomeprazole
    37808-898esomeprazole magnesiumEsomeprazole
    0113-0651good sense esomeprazole magnesiumesomeprazole
    0113-0898Good Sense Esomeprazole MagnesiumEsomeprazole
    0536-1131rugby esomeprazole magnesiumEsomeprazole
    41190-898shoprite esomeprazole magnesiumEsomeprazole
    21130-088signature care esomeprazole magnesiumEsomeprazole
    21130-714signature care esomeprazole magnesiumesomeprazole
    36800-636Topcare Esomeprazole MagnesiumEsomeprazole
    11673-898up and up esomeprazole magnesiumEsomeprazole
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