FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
71335-2442
11-digit product format
713352442
Labeler code
71335
Product ID
71335-2442_41dac660-35a6-dc43-e063-6394a90a6de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215630
Marketing category
ANDA
Marketing start
2023-08-23
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
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
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
71335-2442-1FAMOTIDINE30 in 1 BOTTLETABLET, FILM COATED303
71335-2442-2FAMOTIDINE60 in 1 BOTTLETABLET, FILM COATED603
71335-2442-3FAMOTIDINE100 in 1 BOTTLETABLET, FILM COATED1003
71335-2442-4FAMOTIDINE90 in 1 BOTTLETABLET, FILM COATED903
71335-2442-5FAMOTIDINE15 in 1 BOTTLETABLET, FILM COATED153
71335-2442-6FAMOTIDINE120 in 1 BOTTLETABLET, FILM COATED1203
71335-2442-7FAMOTIDINE20 in 1 BOTTLETABLET, FILM COATED203
71335-2442-8FAMOTIDINE10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2442FAMOTIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, 8 package rows20250402_7cef62ab-1740-4d0f-b6ea-fda783e1c197.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN7cef62ab-1740-4d0f-b6ea-fda783e1c1973
284245famotidine 40 MG Oral TabletSCD7cef62ab-1740-4d0f-b6ea-fda783e1c1973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2442-17133524420130 TABLET, FILM COATED in 1 BOTTLE (71335-2442-1) 2024-07-15NoNoCurrent
71335-2442-27133524420260 TABLET, FILM COATED in 1 BOTTLE (71335-2442-2) 2024-07-15NoNoCurrent
71335-2442-371335244203100 TABLET, FILM COATED in 1 BOTTLE (71335-2442-3) 2024-07-15NoNoCurrent
71335-2442-47133524420490 TABLET, FILM COATED in 1 BOTTLE (71335-2442-4) 2024-07-15NoNoCurrent
71335-2442-57133524420515 TABLET, FILM COATED in 1 BOTTLE (71335-2442-5) 2024-07-15NoNoCurrent
71335-2442-671335244206120 TABLET, FILM COATED in 1 BOTTLE (71335-2442-6) 2024-07-15NoNoCurrent
71335-2442-77133524420720 TABLET, FILM COATED in 1 BOTTLE (71335-2442-7) 2024-07-15NoNoCurrent
71335-2442-87133524420810 TABLET, FILM COATED in 1 BOTTLE (71335-2442-8) 2024-07-15NoNoCurrent