FDA.reportPublic FDA data

Famotidine

Product NDC
71610-399
11-digit product format
716100399
Labeler code
71610
Product ID
71610-399_ce00f657-538e-4b73-9126-1cff453be4aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
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
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
71610-399-30Famotidine30 in 1 BOTTLETABLET302
71610-399-60Famotidine90 in 1 BOTTLETABLET902
71610-399-80Famotidine180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-399-30EA - Each71610-3993fe7cbde-924a-46cf-9ff8-8bf899dda55e12020-08-06
71610-399-60EA - Each71610-3994e32f723-84d6-4ce3-b272-1d6d420baaed12020-04-20
71610-399-80EA - Each71610-399b03bed79-6d81-44c9-9ee9-a44a496736ce12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-399FAMOTIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 3 package rows20200710_b1839d23-20f4-4651-a7d2-8bc3a7583917.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNb1839d23-20f4-4651-a7d2-8bc3a75839172
310273famotidine 20 MG Oral TabletSCDb1839d23-20f4-4651-a7d2-8bc3a75839172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-399-307161003993030 TABLET in 1 BOTTLE (71610-399-30) 30 tablet2020-06-230000-00-00NoNoCurrent
71610-399-607161003996090 TABLET in 1 BOTTLE (71610-399-60) 90 tablet2020-02-210000-00-00NoNoCurrent
71610-399-8071610039980180 TABLET in 1 BOTTLE (71610-399-80) 180 tablet2020-02-210000-00-00NoNoCurrent