FDA.reportPublic FDA data

Famotidine

Product NDC
50268-299
11-digit product format
502680299
Labeler code
50268
Product ID
50268-299_2b48da50-80aa-5a6b-e063-6294a90ac167
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA075718
Marketing category
ANDA
Marketing start
2022-05-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310273

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-299-11Famotidine1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-299-15Famotidine50 in 1 BOXTABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-299-11EA - Each50268-2992f95262b-e500-4da0-bbaf-03aeaddd742812022-07-06
50268-299-15EA - Each50268-29947079c5d-a27b-498b-ad9c-fff2bbfd774012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-299FAMOTIDINE TABLET, FILM COATED [AVPAK]2Current NDC, Legacy NDC, 2 package rows20250112_dfdca61d-8824-6230-e053-2995a90a209d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNdfdca61d-8824-6230-e053-2995a90a209d2
310273famotidine 20 MG Oral TabletSCDdfdca61d-8824-6230-e053-2995a90a209d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-299-11502680299111 in 1 BLISTER PACKHistorical
50268-299-155026802991550 BLISTER PACK in 1 BOX (50268-299-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-299-11) 50 blister pack2022-05-250000-00-00NoNoCurrent