Famotidine

Product NDC
12634-967
11-digit product format
126340967
Labeler code
12634
Product ID
12634-967_277050eb-3e7f-1919-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA075511
Marketing category
ANDA
Marketing start
2001-04-16
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-967-01Famotidine100 in 1 BOTTLETABLET, FILM COATED1008
12634-967-71Famotidine30 in 1 BOTTLETABLET, FILM COATED308
12634-967-80Famotidine20 in 1 BOTTLETABLET, FILM COATED208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-967FAMOTIDINE TABLET, FILM COATED [APOTHECA INC.]8Legacy NDC, 3 package rows20151229_277050eb-3e7e-1919-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN277050eb-3e7e-1919-e054-00144ff88e888
310273famotidine 20 MG Oral TabletSCD277050eb-3e7e-1919-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-967-0112634096701100 in 1 BOTTLEHistorical
12634-967-711263409677130 in 1 BOTTLEHistorical
12634-967-801263409678020 in 1 BOTTLEHistorical