NDC 0591-4187

Esomeprazole

Esomeprazole

Esomeprazole is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Esomeprazole Magnesium Dihydrate.

Product ID0591-4187_18accff4-6d92-4c51-b88d-ecaf77de5db1
NDC0591-4187
Product TypeHuman Otc Drug
Proprietary NameEsomeprazole
Generic NameEsomeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-10-30
Marketing End Date2021-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA209202
Labeler NameActavis Pharma, Inc.
Substance NameESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active Ingredient Strength20 mg/1
NDC Exclude FlagN

Packaging

NDC 0591-4187-14

14 TABLET, DELAYED RELEASE in 1 CARTON (0591-4187-14)
Marketing Start Date2019-10-30
Marketing End Date2021-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-4187-96 [00591418796]

Esomeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209202
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-30

NDC 0591-4187-14 [00591418714]

Esomeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209202
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-30

NDC 0591-4187-42 [00591418742]

Esomeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA209202
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-30

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.