Zegerid OTC

Product NDC
11523-7276
11-digit product format
115237276
Labeler code
11523
Product ID
11523-7276_ef174d5f-22a0-4dd8-e053-2a95a90a2bb8
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole and sodium bicarbonate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
ANDA201361
Marketing category
ANDA
Marketing start
2017-10-01
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20 mg/1; mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-7276-12026-01-29C16284748780-149896155-a3ee-586f-e063-e6dba90add90Zegerid OTC
11523-7276-22026-01-29C16284748780-149896155-a3ee-586f-e063-e6dba90add90Zegerid OTC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7276-1Zegerid OTC1 in 1 CARTONCAPSULE, GELATIN COATED16
11523-7276-1Zegerid OTC14 in 1 BOTTLECAPSULE, GELATIN COATED146
11523-7276-2Zegerid OTC1 in 1 CARTONCAPSULE, GELATIN COATED16
11523-7276-2Zegerid OTC42 in 1 BOTTLECAPSULE, GELATIN COATED426

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7276ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE, GELATIN COATED [BAYER HEALTHCARE LLC.]6Legacy NDC, 4 package rows20241208_5ad1ca2b-3119-b8c2-e053-2a91aa0a2f77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN5ad1ca2b-3119-b8c2-e053-2a91aa0a2f776
646344Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006PSN5ad1ca2b-3119-b8c2-e053-2a91aa0a2f776
646344omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SBD5ad1ca2b-3119-b8c2-e053-2a91aa0a2f776
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD5ad1ca2b-3119-b8c2-e053-2a91aa0a2f776
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY5ad1ca2b-3119-b8c2-e053-2a91aa0a2f776
646344Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SY5ad1ca2b-3119-b8c2-e053-2a91aa0a2f776
646344Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006SY5ad1ca2b-3119-b8c2-e053-2a91aa0a2f776
646344Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral CapsuleSY5ad1ca2b-3119-b8c2-e053-2a91aa0a2f776

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7276-1115237276011 BOTTLE in 1 CARTON (11523-7276-1) > 14 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2017-10-010000-00-00NoNoCurrent
11523-7276-2115237276021 BOTTLE in 1 CARTON (11523-7276-2) > 42 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2017-10-010000-00-00NoNoCurrent