FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
60760-843
11-digit product format
607600843
Labeler code
60760
Product ID
60760-843_50c43530-2461-ff82-e063-6394a90a6c4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA215630
Marketing category
ANDA
Marketing start
2022-07-08
Substance
FAMOTIDINE
Active strength
40 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FAMOTIDINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui284245

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
60760-843-07FAMOTIDINE7 in 1 BOTTLE, PLASTICTABLET, FILM COATED72
60760-843-60FAMOTIDINE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-843-07EA - Each60760-843239768e7-839a-4d82-9897-fcd1d085358612023-08-08
60760-843-60EA - Each60760-843082155cd-cfc7-41f9-a115-998fcb17641212023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-843FAMOTIDINE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 2 package rows20230718_febe39b1-9212-a281-e053-6394a90a1a9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNfebe39b1-9212-a281-e053-6394a90a1a9f2
284245famotidine 40 MG Oral TabletSCDfebe39b1-9212-a281-e053-6394a90a1a9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-843-07607600843077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-843-07) 2023-06-20NoNoHistorical
60760-843-606076008436060 in 1 BOTTLE, PLASTICHistorical