FDA.reportPublic FDA data

Famotidine

Product NDC
46122-735
11-digit product format
461220735
Labeler code
46122
Product ID
46122-735_791e2d0f-6c6d-4b46-9b4b-a672a7452967
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA206531
Marketing category
ANDA
Marketing start
2023-07-27
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
46122-735-65Famotidine30 in 1 BOTTLETABLET, FILM COATED303
46122-735-65Famotidine1 in 1 CARTONTABLET, FILM COATED13
46122-735-75Famotidine1 in 1 CARTONTABLET, FILM COATED13
46122-735-75Famotidine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-735-75EA - Each46122-735511dfac2-2939-45d2-9447-842aafaa258212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-735FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]3Current NDC, 4 package rows20250403_a5d88925-efca-4240-9eb5-6a9d0ac7a67e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSNa5d88925-efca-4240-9eb5-6a9d0ac7a67e3
199047famotidine 10 MG Oral TabletSCDa5d88925-efca-4240-9eb5-6a9d0ac7a67e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-735-65461220735651 BOTTLE in 1 CARTON (46122-735-65) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-09-28NoNoCurrent
46122-735-75461220735751 BOTTLE in 1 CARTON (46122-735-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-07-27NoNoCurrent