FDA.reportPublic FDA data

Famotidine

Product NDC
0363-1899
11-digit product format
003631899
Labeler code
0363
Product ID
0363-1899_f1138f9a-9f0a-46ee-b1de-ee1baea25269
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA206531
Marketing category
ANDA
Marketing start
2022-02-18
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
0363-1899-14Famotidine1 in 1 CARTONTABLET, FILM COATED14
0363-1899-14Famotidine50 in 1 BOTTLETABLET, FILM COATED504
0363-1899-24Famotidine1 in 1 CARTONTABLET, FILM COATED14
0363-1899-24Famotidine90 in 1 BOTTLETABLET, FILM COATED904
0363-1899-34Famotidine1 in 1 CARTONTABLET, FILM COATED14
0363-1899-34Famotidine200 in 1 BOTTLETABLET, FILM COATED2004
0363-1899-53Famotidine25 in 1 BOTTLETABLET, FILM COATED254
0363-1899-53Famotidine1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1899FAMOTIDINE TABLET, FILM COATED [WALGREEN CO.]4Current NDC, Legacy NDC, 8 package rows20250425_d0f74e78-7afb-49c2-e053-2a95a90a31dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNd0f74e78-7afb-49c2-e053-2a95a90a31dc4
310273famotidine 20 MG Oral TabletSCDd0f74e78-7afb-49c2-e053-2a95a90a31dc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1899-14003631899141 BOTTLE in 1 CARTON (0363-1899-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-180000-00-00NoNoCurrent
0363-1899-24003631899241 BOTTLE in 1 CARTON (0363-1899-24) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-180000-00-00NoNoCurrent
0363-1899-34003631899341 BOTTLE in 1 CARTON (0363-1899-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-180000-00-00NoNoCurrent
0363-1899-53003631899531 BOTTLE in 1 CARTON (0363-1899-53) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-180000-00-00NoNoCurrent