FDA.reportPublic FDA data

Famotidine

Product NDC
71335-0409
11-digit product format
713350409
Labeler code
71335
Product ID
71335-0409_d24aad6a-0ce6-45d1-a84a-2e738c497bb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078916
Marketing category
ANDA
Marketing start
2016-01-29
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0409-0Famotidine40 in 1 BOTTLETABLET40102
71335-0409-1Famotidine30 in 1 BOTTLETABLET30102
71335-0409-2Famotidine60 in 1 BOTTLETABLET60102
71335-0409-3Famotidine20 in 1 BOTTLETABLET20102
71335-0409-4Famotidine90 in 1 BOTTLETABLET90102
71335-0409-5Famotidine100 in 1 BOTTLETABLET100102
71335-0409-6Famotidine10 in 1 BOTTLETABLET10102
71335-0409-7Famotidine120 in 1 BOTTLETABLET120102
71335-0409-8Famotidine50 in 1 BOTTLETABLET50102
71335-0409-9Famotidine14 in 1 BOTTLETABLET14102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0409-1EA - Each71335-0409a3a1bd41-0b94-4616-8403-ba320ce7851a12018-02-20
71335-0409-2EA - Each71335-040979416866-af77-42e3-b731-4f0dff7bab3512018-02-20
71335-0409-3EA - Each71335-0409fdf71743-84f5-4521-b302-8ec9868bf71b12018-02-20
71335-0409-4EA - Each71335-040960dfa041-da67-4f2a-905d-5e98175947e212018-02-20
71335-0409-5EA - Each71335-04097a827df7-5c11-4799-bf8d-d8e3b78ce23f12018-02-20
71335-0409-6EA - Each71335-0409f974c1f6-7548-4f03-b242-94eb5a79295112018-02-20
71335-0409-7EA - Each71335-0409a0c2df66-2b4d-4011-ad05-66ffb1357b0512018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0409FAMOTIDINE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20231201_cf2cd30e-9a0f-4b63-975c-5b551691cda9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNcf2cd30e-9a0f-4b63-975c-5b551691cda9102
310273famotidine 20 MG Oral TabletSCDcf2cd30e-9a0f-4b63-975c-5b551691cda9102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0409-07133504090040 TABLET in 1 BOTTLE (71335-0409-0) 40 tablet2026-05-21NoNoCurrent
71335-0409-17133504090130 TABLET in 1 BOTTLE (71335-0409-1) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-0409-27133504090260 TABLET in 1 BOTTLE (71335-0409-2) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-0409-37133504090320 TABLET in 1 BOTTLE (71335-0409-3) 20 tablet2022-02-090000-00-00NoNoCurrent
71335-0409-47133504090490 TABLET in 1 BOTTLE (71335-0409-4) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-0409-571335040905100 TABLET in 1 BOTTLE (71335-0409-5) 100 tablet2022-02-090000-00-00NoNoCurrent
71335-0409-67133504090610 TABLET in 1 BOTTLE (71335-0409-6) 10 tablet2022-02-090000-00-00NoNoCurrent
71335-0409-771335040907120 TABLET in 1 BOTTLE (71335-0409-7) 120 tablet2022-02-090000-00-00NoNoCurrent
71335-0409-87133504090850 TABLET in 1 BOTTLE (71335-0409-8) 50 tablet2022-02-090000-00-00NoNoCurrent
71335-0409-97133504090914 TABLET in 1 BOTTLE (71335-0409-9) 14 tablet2026-05-21NoNoCurrent