FDA.reportPublic FDA data

Famotidine

Product NDC
21130-033
11-digit product format
211300033
Labeler code
21130
Product ID
21130-033_40a6d1b8-f8bd-4d21-9bde-425d5e9e2c8b
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Better Living Brands, LLC
Application
ANDA206531
Marketing category
ANDA
Marketing start
2023-09-08
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
21130-033-14Famotidine1 in 1 CARTONTABLET, FILM COATED13
21130-033-14Famotidine50 in 1 BOTTLETABLET, FILM COATED503
21130-033-34Famotidine200 in 1 BOTTLETABLET, FILM COATED2003
21130-033-34Famotidine1 in 1 CARTONTABLET, FILM COATED13
21130-033-53Famotidine25 in 1 BOTTLETABLET, FILM COATED253
21130-033-53Famotidine1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-033FAMOTIDINE TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]3Current NDC, 6 package rows20250426_f6f0230c-44fb-6c36-e053-6394a90ac43e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNf6f0230c-44fb-6c36-e053-6394a90ac43e3
310273famotidine 20 MG Oral TabletSCDf6f0230c-44fb-6c36-e053-6394a90ac43e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-033-14211300033141 BOTTLE in 1 CARTON (21130-033-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-09-08NoNoCurrent
21130-033-34211300033341 BOTTLE in 1 CARTON (21130-033-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-09-08NoNoCurrent
21130-033-53211300033531 BOTTLE in 1 CARTON (21130-033-53) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-09-08NoNoCurrent