NDC 70518-2038

NEXIUM

Esomeprazole Magnesium

NEXIUM is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Esomeprazole Magnesium.

Product ID70518-2038_8774b7a5-53fe-2e94-e053-2a95a90ae1f3
NDC70518-2038
Product TypeHuman Prescription Drug
Proprietary NameNEXIUM
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-04-26
Marketing CategoryNDA / NDA
Application NumberNDA021153
Labeler NameREMEDYREPACK INC.
Substance NameESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2038-0

20 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2038-0)
Marketing Start Date2019-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2038-0 [70518203800]

NEXIUM CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA021153
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-26

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 mg/1

Pharmacological Class

  • Proton Pump Inhibitor [EPC]
  • Proton Pump Inhibitors [MoA]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Proton Pump Inhibitor [EPC]
  • Proton Pump Inhibitors [MoA]
  • Cytochrome P450 2C19 Inhibitors [MoA]

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

NDCBrand NameGeneric Name
0186-4010NEXIUMEsomeprazole magnesium
0186-4020NEXIUMEsomeprazole magnesium
0186-4025NEXIUMEsomeprazole magnesium
21695-092NEXIUMNEXIUM
21695-091NEXIUMNEXIUM
0186-4040NEXIUMNEXIUM
0186-5040NEXIUMNEXIUM
0186-5020NEXIUMNEXIUM
0186-4050NEXIUMNEXIUM
50090-0742NEXIUMNEXIUM
49999-307NEXIUMNEXIUM
50436-3121NEXIUMNEXIUM
55154-9616NEXIUMNEXIUM
55700-046NEXIUMNEXIUM
61919-509NEXIUMNEXIUM
63629-3311NEXIUMNEXIUM
70518-2038NEXIUMNEXIUM
80425-0111NexiumNexium
0093-6450Esomeprazole MagnesiumEsomeprazole Magnesium
0093-6451Esomeprazole MagnesiumEsomeprazole Magnesium
0186-0382Esomeprazole magnesiumEsomeprazole magnesium
0186-0384Esomeprazole magnesiumEsomeprazole magnesium

Trademark Results [NEXIUM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEXIUM
NEXIUM
76155804 not registered Dead/Abandoned
Bimini Bay Outfitters, Ltd.
2000-10-27
NEXIUM
NEXIUM
75646020 2483060 Live/Registered
ASTRA AKTIEBOLAG
1999-02-22
NEXIUM
NEXIUM
74309333 1807883 Dead/Cancelled
RICHARDS, CHRISTOS
1992-08-31

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