Famotidine

Product NDC
72559-038
11-digit product format
725590038
Labeler code
72559
Product ID
72559-038_39334fb3-e395-7819-e063-6294a90a9073
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Little Pharma, Inc.
Application
ANDA215766
Marketing category
ANDA
Marketing start
2025-05-15
Substance
FAMOTIDINE
Active strength
10 mg/10mg
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
FAMOTIDINE10 mg/10mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047

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
72559-038-23Famotidine300 mg in 1 BOTTLETABLET3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72559-038FAMOTIDINE TABLET [LITTLE PHARMA, INC.]1Current NDC, 1 package rows20250515_33dc93a5-ee03-2e68-e063-6294a90aeee1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN33dc93a5-ee03-2e68-e063-6294a90aeee12
199047famotidine 10 MG Oral TabletSCD33dc93a5-ee03-2e68-e063-6294a90aeee12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72559-038-2372559003823300 mg in 1 BOTTLE (72559-038-23) 300 mg2025-05-15NoNoHistorical