NDC 68012-054

ZEGERID

Omeprazole And Sodium Bicarbonate

ZEGERID is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Santarus, Inc... The primary component is Omeprazole; Sodium Bicarbonate.

Product ID68012-054_00549015-8d70-46e3-b7a7-5993e6d858ca
NDC68012-054
Product TypeHuman Prescription Drug
Proprietary NameZEGERID
Generic NameOmeprazole And Sodium Bicarbonate
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date2014-06-15
Marketing CategoryNDA / NDA
Application NumberNDA021636
Labeler NameSantarus, Inc..
Substance NameOMEPRAZOLE; SODIUM BICARBONATE
Active Ingredient Strength40 mg/1; mg/1
Pharm ClassesAlkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68012-054-03

3 PACKET in 1 CARTON (68012-054-03) > 1 POWDER, FOR SUSPENSION in 1 PACKET
Marketing Start Date2014-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68012-054-03 [68012005403]

ZEGERID POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA021636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-15

NDC 68012-054-01 [68012005401]

ZEGERID POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA021636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-15
Marketing End Date2015-12-01

NDC 68012-054-30 [68012005430]

ZEGERID POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA021636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-15

Drug Details

Pharmacological Class

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

Medicade Reported Pricing

68012005430 ZEGERID 40 MG PACKET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "ZEGERID" or generic name "Omeprazole And Sodium Bicarbonate"

NDCBrand NameGeneric Name
68012-102ZEGERIDZEGERID
68012-052ZEGERIDZEGERID
68012-054ZEGERIDZEGERID
68012-104ZEGERIDZEGERID
13107-115Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
13107-116Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
13107-117Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
16714-508Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
16714-509Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
27241-029Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
27241-030Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
27241-031Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
27241-032Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
50228-363Omeprazole and Sodium BicarbonateOmeprazole and Sodium Bicarbonate
42291-585Omeprazole/BicarbonateOmeprazole and Sodium Bicarbonate
49884-268Omeprazole/Sodium BicarbonateOmeprazole and Sodium Bicarbonate
49884-269Omeprazole/Sodium BicarbonateOmeprazole and Sodium Bicarbonate
11523-7265Zegerid OTCOmeprazole and Sodium Bicarbonate
11523-7276Zegerid OTComeprazole and sodium bicarbonate

Trademark Results [ZEGERID]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZEGERID
ZEGERID
78519703 3041325 Live/Registered
SANTARUS, INC.
2004-11-18
ZEGERID
ZEGERID
78332533 2929881 Live/Registered
Santarus, Inc.
2003-11-24

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