FDA.reportPublic FDA data

Famotidine

Product NDC
71205-276
11-digit product format
712050276
Labeler code
71205
Product ID
71205-276_38e967e3-f465-48f7-9a0f-ac32a52d6c78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075511
Marketing category
ANDA
Marketing start
2001-04-16
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
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
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
71205-276-06Famotidine6 in 1 BOTTLETABLET, FILM COATED68
71205-276-10Famotidine10 in 1 BOTTLETABLET, FILM COATED108
71205-276-30Famotidine30 in 1 BOTTLETABLET, FILM COATED308
71205-276-60Famotidine60 in 1 BOTTLETABLET, FILM COATED608
71205-276-67Famotidine270 in 1 BOTTLETABLET, FILM COATED2708
71205-276-78Famotidine180 in 1 BOTTLETABLET, FILM COATED1808
71205-276-90Famotidine90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-276FAMOTIDINE TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 7 package rows20240927_d60bde93-f512-4071-9e4b-1d8318def3bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNd60bde93-f512-4071-9e4b-1d8318def3bc8
310273famotidine 20 MG Oral TabletSCDd60bde93-f512-4071-9e4b-1d8318def3bc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-276-06712050276066 TABLET, FILM COATED in 1 BOTTLE (71205-276-06) 2021-07-080000-00-00NoNoCurrent
71205-276-107120502761010 TABLET, FILM COATED in 1 BOTTLE (71205-276-10) 2019-05-010000-00-00NoNoCurrent
71205-276-207120502762020 TABLET, FILM COATED in 1 BOTTLE (71205-276-20) 2019-05-010000-00-00NoNoCurrent
71205-276-307120502763030 TABLET, FILM COATED in 1 BOTTLE (71205-276-30) 2019-05-010000-00-00NoNoCurrent
71205-276-607120502766060 TABLET, FILM COATED in 1 BOTTLE (71205-276-60) 2019-05-010000-00-00NoNoCurrent
71205-276-6771205027667270 TABLET, FILM COATED in 1 BOTTLE (71205-276-67) 2024-09-23NoNoCurrent
71205-276-7871205027678180 TABLET, FILM COATED in 1 BOTTLE (71205-276-78) 2025-07-10NoNoCurrent
71205-276-907120502769090 TABLET, FILM COATED in 1 BOTTLE (71205-276-90) 2026-03-130000-00-00NoNoCurrent