FDA.reportPublic FDA data

ZEGERID

Product NDC
68012-054
11-digit product format
680120054
Labeler code
68012
Product ID
68012-054_1d076bd0-8cc0-4327-8032-9a307fc89e71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole and sodium bicarbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Santarus, Inc..
Application
NDA021636
Marketing category
NDA
Marketing start
2014-06-15
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40; 1680 mg/1; mg/1
Pharmacologic classes
Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZEGERID
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1
SODIUM BICARBONATE1680 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9, 8MDF5V39QO
Rxcui616539, 616541, 646344, 646352, 753557, 753562, 753601, 753603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68012-054-03ZEGERID3 in 1 CARTONPOWDER, FOR SUSPENSION353
68012-054-03ZEGERID1 in 1 PACKETPOWDER, FOR SUSPENSION153
68012-054-30ZEGERID30 in 1 CARTONPOWDER, FOR SUSPENSION3053
68012-054-30ZEGERID1 in 1 PACKETPOWDER, FOR SUSPENSION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68012-054-01EA - Each68012-05424348c24-2d7c-4d1b-8721-c5c80e04cb6c12014-02-04
68012-054-30EA - Each68012-054f5843b1f-fc0b-4dfe-b164-601296389fdd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
OMEPRAZOLEACTIVE MOIETYKG60484QX9ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
SUCROSEINACTIVE INGREDIENTC151H8M554ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.]32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68012-054ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [SANTARUS, INC..]52Current NDC, Legacy NDC, 4 package rows20230729_cd6868b9-5824-442b-8d65-4db29ecb70a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSNcd6868b9-5824-442b-8d65-4db29ecb70a453
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNcd6868b9-5824-442b-8d65-4db29ecb70a453
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSNcd6868b9-5824-442b-8d65-4db29ecb70a453
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNcd6868b9-5824-442b-8d65-4db29ecb70a453
646344Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006PSNcd6868b9-5824-442b-8d65-4db29ecb70a453
753603Zegerid 20 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006PSNcd6868b9-5824-442b-8d65-4db29ecb70a453
646352Zegerid 40 MG / 1100 MG Oral Capsule, Reformulated Aug 2006PSNcd6868b9-5824-442b-8d65-4db29ecb70a453
753601Zegerid 40 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006PSNcd6868b9-5824-442b-8d65-4db29ecb70a453
646344omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SBDcd6868b9-5824-442b-8d65-4db29ecb70a453
753603omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006]SBDcd6868b9-5824-442b-8d65-4db29ecb70a453
646352omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SBDcd6868b9-5824-442b-8d65-4db29ecb70a453
753601omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006]SBDcd6868b9-5824-442b-8d65-4db29ecb70a453
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDcd6868b9-5824-442b-8d65-4db29ecb70a453
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDcd6868b9-5824-442b-8d65-4db29ecb70a453
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDcd6868b9-5824-442b-8d65-4db29ecb70a453
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDcd6868b9-5824-442b-8d65-4db29ecb70a453
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSYcd6868b9-5824-442b-8d65-4db29ecb70a453
646344Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SYcd6868b9-5824-442b-8d65-4db29ecb70a453
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYcd6868b9-5824-442b-8d65-4db29ecb70a453
753603Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006]SYcd6868b9-5824-442b-8d65-4db29ecb70a453
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSYcd6868b9-5824-442b-8d65-4db29ecb70a453
646352Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SYcd6868b9-5824-442b-8d65-4db29ecb70a453
753557Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYcd6868b9-5824-442b-8d65-4db29ecb70a453
753601Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006]SYcd6868b9-5824-442b-8d65-4db29ecb70a453
646344Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006SYcd6868b9-5824-442b-8d65-4db29ecb70a453
753603Zegerid (omeprazole 20 MG / sodium bicarbonate 1680 MG) Powder for Oral Suspension, Reformulated Aug 2006SYcd6868b9-5824-442b-8d65-4db29ecb70a453
753601Zegerid (omeprazole 40 MG / sodium bicarbonate 1680 MG) Powder for Oral Suspension, Reformulated Aug 2006SYcd6868b9-5824-442b-8d65-4db29ecb70a453
753603Zegerid 20 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006SYcd6868b9-5824-442b-8d65-4db29ecb70a453
753601Zegerid 40 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006SYcd6868b9-5824-442b-8d65-4db29ecb70a453
646344Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral CapsuleSYcd6868b9-5824-442b-8d65-4db29ecb70a453
646352Zegerid Reformulated Aug 2006 (omeprazole 40 MG / sodium bicarbonate 1100 MG) Oral CapsuleSYcd6868b9-5824-442b-8d65-4db29ecb70a453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68012-054-03680120054033 PACKET in 1 CARTON (68012-054-03) / 1 POWDER, FOR SUSPENSION in 1 PACKET3 packet2014-06-150000-00-00NoNoCurrent
68012-054-306801200543030 PACKET in 1 CARTON (68012-054-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2014-06-150000-00-00NoNoCurrent