FDA.reportPublic FDA data

Famotidine

Product NDC
71205-634
11-digit product format
712050634
Labeler code
71205
Product ID
71205-634_c3f19a52-d462-4fd5-8a28-ce6caac442ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206530
Marketing category
ANDA
Marketing start
2015-12-22
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
71205-634-30Famotidine30 in 1 BOTTLETABLET, FILM COATED302
71205-634-60Famotidine60 in 1 BOTTLETABLET, FILM COATED602
71205-634-90Famotidine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-634-30EA - Each71205-6340a7a3a6d-5ffe-452f-8dca-b62ead32d3ff12022-06-06
71205-634-90EA - Each71205-634941caf88-5bc9-471d-bd3e-bb019f9800ec12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-634FAMOTIDINE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20221005_f32d0929-de22-4bec-9e24-bb549cf2679f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNf32d0929-de22-4bec-9e24-bb549cf2679f2
284245famotidine 40 MG Oral TabletSCDf32d0929-de22-4bec-9e24-bb549cf2679f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-634-307120506343030 TABLET, FILM COATED in 1 BOTTLE (71205-634-30) 2022-01-260000-00-00NoNoCurrent
71205-634-607120506346060 TABLET, FILM COATED in 1 BOTTLE (71205-634-60) 2022-01-260000-00-00NoNoCurrent
71205-634-907120506349090 TABLET, FILM COATED in 1 BOTTLE (71205-634-90) 2022-01-260000-00-00NoNoCurrent