Famotidine

Product NDC
45865-881
11-digit product format
458650881
Labeler code
45865
Product ID
45865-881_9ab48913-6850-9988-e053-2995a90afeb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
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
2020-12-31
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
45865-881-51Famotidine120 in 1 BOTTLETABLET, FILM COATED1203
45865-881-60Famotidine60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-881FAMOTIDINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 2 package rows20240302_7dc845a4-d0dd-41c5-e053-2a91aa0ae5b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN7dc845a4-d0dd-41c5-e053-2a91aa0ae5b33
310273famotidine 20 MG Oral TabletSCD7dc845a4-d0dd-41c5-e053-2a91aa0ae5b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-881-5145865088151120 TABLET, FILM COATED in 1 BOTTLE (45865-881-51) 2018-06-010000-00-00NoNoCurrent
45865-881-604586508816060 TABLET, FILM COATED in 1 BOTTLE (45865-881-60) 2018-06-010000-00-00NoNoCurrent