NDC 69238-1050

Esomeprazole Magnesium

Esomeprazole Magnesium

Esomeprazole Magnesium is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Esomeprazole Magnesium.

Product ID69238-1050_0208a196-14c6-4577-90f3-fb48f38a3cd5
NDC69238-1050
Product TypeHuman Otc Drug
Proprietary NameEsomeprazole Magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA209716
Labeler NameAmneal Pharmaceuticals NY LLC
Substance NameESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69238-1050-1

1 BOTTLE in 1 BLISTER PACK (69238-1050-1) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4)
Marketing Start Date2019-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1050-3 [69238105003]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209716
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-05

NDC 69238-1050-1 [69238105001]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209716
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-05

NDC 69238-1050-9 [69238105009]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209716
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-05

NDC 69238-1050-4 [69238105004]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209716
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-05

NDC 69238-1050-5 [69238105005]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209716
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-05

NDC 69238-1050-8 [69238105008]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209716
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-05

NDC 69238-1050-2 [69238105002]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209716
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-05

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

OpenFDA Data

SPL SET ID:d13c22be-f5bd-4ea8-8081-bdfac9e7fb1b
Manufacturer
UNII

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

NDCBrand NameGeneric Name
0093-6450Esomeprazole MagnesiumEsomeprazole Magnesium
0093-6451Esomeprazole MagnesiumEsomeprazole Magnesium
0186-0382Esomeprazole magnesiumEsomeprazole magnesium
0186-0384Esomeprazole magnesiumEsomeprazole magnesium
67877-479Esomeprazole magnesiumEsomeprazole magnesium
67877-478Esomeprazole magnesiumEsomeprazole magnesium
68016-007Esomeprazole MagnesiumEsomeprazole Magnesium
68071-3179ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
68071-4213ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
68071-4212Esomeprazole MagnesiumEsomeprazole Magnesium
68071-4457Esomeprazole MagnesiumEsomeprazole Magnesium
68071-4536Esomeprazole MagnesiumEsomeprazole Magnesium
68071-4825Esomeprazole MagnesiumEsomeprazole Magnesium
68196-977Esomeprazole MagnesiumEsomeprazole Magnesium
68788-7201Esomeprazole MagnesiumEsomeprazole Magnesium
68788-6922ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
69842-898esomeprazole magnesiumesomeprazole magnesium
69842-277Esomeprazole MagnesiumEsomeprazole Magnesium
70518-0044ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
70677-0069Esomeprazole MagnesiumEsomeprazole Magnesium
71335-0987Esomeprazole magnesiumEsomeprazole magnesium
71335-0709Esomeprazole MagnesiumEsomeprazole Magnesium
71335-0807Esomeprazole MagnesiumEsomeprazole Magnesium
71335-0052ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
72036-800Esomeprazole MagnesiumEsomeprazole Magnesium
0904-6581Esomeprazole MagnesiumEsomeprazole Magnesium
0904-6580Esomeprazole MagnesiumEsomeprazole Magnesium
11822-0898esomeprazole magnesiumesomeprazole magnesium
13668-154ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
13668-155ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
16714-735Esomeprazole MagnesiumEsomeprazole Magnesium
16714-736Esomeprazole MagnesiumEsomeprazole Magnesium
30142-413esomeprazole magnesiumesomeprazole magnesium
31722-573Esomeprazole MagnesiumEsomeprazole Magnesium
31722-572Esomeprazole MagnesiumEsomeprazole Magnesium
30142-261Esomeprazole MagnesiumEsomeprazole Magnesium
37012-898esomeprazole magnesiumesomeprazole magnesium
37808-898esomeprazole magnesiumesomeprazole magnesium
37808-115Esomeprazole MagnesiumEsomeprazole Magnesium
41250-900esomeprazole magnesiumesomeprazole magnesium
42292-010Esomeprazole MagnesiumEsomeprazole Magnesium
42292-009Esomeprazole MagnesiumEsomeprazole Magnesium
42708-024Esomeprazole MagnesiumEsomeprazole Magnesium
43598-407Esomeprazole MagnesiumEsomeprazole Magnesium
43598-812Esomeprazole MagnesiumEsomeprazole Magnesium
43598-509Esomeprazole MagnesiumEsomeprazole Magnesium
43598-510Esomeprazole MagnesiumEsomeprazole Magnesium
46122-538Esomeprazole MagnesiumEsomeprazole Magnesium
45865-892Esomeprazole MagnesiumEsomeprazole Magnesium
48792-7843esomeprazole magnesiumesomeprazole magnesium

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