Famotidine

Product NDC
0363-4400
11-digit product format
003634400
Labeler code
0363
Product ID
0363-4400_7330a3e3-b645-4725-9565-41a7540a1b18
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA206531
Marketing category
ANDA
Marketing start
2016-04-26
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
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/1

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
0363-4400-19Famotidine1 in 1 CARTONTABLET, FILM COATED19
0363-4400-19Famotidine90 in 1 BOTTLETABLET, FILM COATED909
0363-4400-32Famotidine180 in 1 BOTTLETABLET, FILM COATED1809
0363-4400-32Famotidine1 in 1 CARTONTABLET, FILM COATED19
0363-4400-84Famotidine1 in 1 CARTONTABLET, FILM COATED19
0363-4400-84Famotidine30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4400FAMOTIDINE TABLET, FILM COATED [WALGREEN CO.]9Current NDC, Legacy NDC, 6 package rows20250321_316e3815-6ae1-47c3-8a75-fd57f8434a6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN316e3815-6ae1-47c3-8a75-fd57f8434a6f9
199047famotidine 10 MG Oral TabletSCD316e3815-6ae1-47c3-8a75-fd57f8434a6f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4400-19003634400191 BOTTLE in 1 CARTON (0363-4400-19) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
0363-4400-32003634400321 BOTTLE in 1 CARTON (0363-4400-32) / 180 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-180000-00-00NoNoCurrent
0363-4400-84003634400841 BOTTLE in 1 CARTON (0363-4400-84) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-05-130000-00-00NoNoCurrent