FDA.reportPublic FDA data

Famotidine

Product NDC
71335-2527
11-digit product format
713352527
Labeler code
71335
Product ID
71335-2527_cbbe43d7-709c-4f58-8472-ec692825c168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215767
Marketing category
ANDA
Marketing start
2021-11-04
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
71335-2527-1Famotidine30 in 1 BOTTLETABLET, FILM COATED302
71335-2527-2Famotidine60 in 1 BOTTLETABLET, FILM COATED602
71335-2527-3Famotidine100 in 1 BOTTLETABLET, FILM COATED1002
71335-2527-4Famotidine90 in 1 BOTTLETABLET, FILM COATED902
71335-2527-5Famotidine15 in 1 BOTTLETABLET, FILM COATED152
71335-2527-6Famotidine120 in 1 BOTTLETABLET, FILM COATED1202
71335-2527-7Famotidine20 in 1 BOTTLETABLET, FILM COATED202
71335-2527-8Famotidine10 in 1 BOTTLETABLET, FILM COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2527FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 8 package rows20241127_e034546b-28cb-41aa-9441-655cdb966554.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNe034546b-28cb-41aa-9441-655cdb9665542
284245famotidine 40 MG Oral TabletSCDe034546b-28cb-41aa-9441-655cdb9665542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2527-17133525270130 TABLET, FILM COATED in 1 BOTTLE (71335-2527-1) 2024-11-25NoNoHistorical
71335-2527-27133525270260 TABLET, FILM COATED in 1 BOTTLE (71335-2527-2) 2024-11-25NoNoHistorical
71335-2527-371335252703100 TABLET, FILM COATED in 1 BOTTLE (71335-2527-3) 2024-11-25NoNoHistorical
71335-2527-47133525270490 TABLET, FILM COATED in 1 BOTTLE (71335-2527-4) 2024-11-25NoNoHistorical
71335-2527-57133525270515 TABLET, FILM COATED in 1 BOTTLE (71335-2527-5) 2024-11-25NoNoHistorical
71335-2527-671335252706120 TABLET, FILM COATED in 1 BOTTLE (71335-2527-6) 2024-11-25NoNoHistorical
71335-2527-77133525270720 TABLET, FILM COATED in 1 BOTTLE (71335-2527-7) 2024-11-25NoNoHistorical
71335-2527-87133525270810 TABLET, FILM COATED in 1 BOTTLE (71335-2527-8) 2024-11-25NoNoHistorical