NDC 63304-740

Esomeprazole

Esomeprazole

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

Product ID63304-740_6ac3f3a4-98df-4eb3-9b9e-c85253811b85
NDC63304-740
Product TypeHuman Otc Drug
Proprietary NameEsomeprazole
Generic NameEsomeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA212866
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63304-740-14

1 BOTTLE in 1 CARTON (63304-740-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2019-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-740-27 [63304074027]

Esomeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA212866
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-11-30

NDC 63304-740-14 [63304074014]

Esomeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA212866
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-11-30

NDC 63304-740-44 [63304074044]

Esomeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA212866
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-11-30

Drug Details

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.