Zantac 360

Product NDC
52904-926
11-digit product format
529040926
Labeler code
52904
Product ID
52904-926_2332d799-0c86-4b40-b0f8-9571bdfe266e
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Select Corporation
Application
ANDA206531
Marketing category
ANDA
Marketing start
2021-04-12
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
10 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
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
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-926-042024-01-30C16284748780-11030e365-316c-111a-e063-dadaa90a10e2Zantac 360°™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-926-04Zantac 3601 in 1 BLISTER PACKTABLET, FILM COATED11
52904-926-04Zantac 3601 in 1 POUCHTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-926ZANTAC 360 (FAMOTIDINE) TABLET, FILM COATED [SELECT CORPORATION]1Legacy NDC, 2 package rows20220415_228b4c42-eef3-45c9-b48d-cbfb9d816c54.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-926-04529040926041 POUCH in 1 BLISTER PACK (52904-926-04) > 1 TABLET, FILM COATED in 1 POUCH1 pouch2021-04-120000-00-00NoNoCurrent