FDA.reportPublic FDA data

Famotidine

Product NDC
63187-723
11-digit product format
631870723
Labeler code
63187
Product ID
63187-723_c34993a0-b4e0-4443-a5b7-1fc9e2b019f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
63187-723-00Famotidine100 in 1 BOTTLETABLET1006
63187-723-06Famotidine6 in 1 BOTTLETABLET66
63187-723-10Famotidine10 in 1 BOTTLETABLET106
63187-723-30Famotidine30 in 1 BOTTLETABLET306
63187-723-60Famotidine60 in 1 BOTTLETABLET606
63187-723-90Famotidine90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-723-06EA - Each63187-723d88159f0-8adf-4d1e-b787-5f590af9041412019-11-12
63187-723-60EA - Each63187-7233187c6ac-d161-43cd-a76b-d66a334b61bb12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-723FAMOTIDINE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20220528_9baf2596-b771-4bae-a03c-d3af6716821d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN9baf2596-b771-4bae-a03c-d3af6716821d6
310273famotidine 20 MG Oral TabletSCD9baf2596-b771-4bae-a03c-d3af6716821d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-723-0063187072300100 TABLET in 1 BOTTLE (63187-723-00) 100 tablet2016-06-010000-00-00NoNoCurrent
63187-723-06631870723066 TABLET in 1 BOTTLE (63187-723-06) 6 tablet2019-09-010000-00-00NoNoCurrent
63187-723-106318707231010 TABLET in 1 BOTTLE (63187-723-10) 10 tablet2016-11-010000-00-00NoNoCurrent
63187-723-306318707233030 TABLET in 1 BOTTLE (63187-723-30) 30 tablet2016-06-010000-00-00NoNoCurrent
63187-723-606318707236060 TABLET in 1 BOTTLE (63187-723-60) 60 tablet2016-06-010000-00-00NoNoCurrent
63187-723-906318707239090 TABLET in 1 BOTTLE (63187-723-90) 90 tablet2016-06-010000-00-00NoNoCurrent