FDA.reportPublic FDA data

Famotidine

Product NDC
71335-2190
11-digit product format
713352190
Labeler code
71335
Product ID
71335-2190_ca5b10e6-83a5-475c-8a04-9621381afcfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216441
Marketing category
ANDA
Marketing start
2022-06-06
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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2190-1Famotidine30 in 1 BOTTLETABLET, FILM COATED30104
71335-2190-2Famotidine60 in 1 BOTTLETABLET, FILM COATED60104
71335-2190-3Famotidine20 in 1 BOTTLETABLET, FILM COATED20104
71335-2190-4Famotidine90 in 1 BOTTLETABLET, FILM COATED90104
71335-2190-5Famotidine100 in 1 BOTTLETABLET, FILM COATED100104
71335-2190-6Famotidine10 in 1 BOTTLETABLET, FILM COATED10104
71335-2190-7Famotidine120 in 1 BOTTLETABLET, FILM COATED120104
71335-2190-8Famotidine50 in 1 BOTTLETABLET, FILM COATED50104
71335-2190-9Famotidine14 in 1 BOTTLETABLET, FILM COATED14104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2190-1EA - Each71335-2190afd33edd-89ef-48f1-a0d9-e0cae1de519b12023-12-05
71335-2190-2EA - Each71335-2190ea7806bd-a9f7-43c2-b48e-bbc1025672bb12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2190FAMOTIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 9 package rows20240824_72a97532-9a79-4cbf-b9d0-22ce1f21468d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN72a97532-9a79-4cbf-b9d0-22ce1f21468d104
310273famotidine 20 MG Oral TabletSCD72a97532-9a79-4cbf-b9d0-22ce1f21468d104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2190-17133521900130 TABLET, FILM COATED in 1 BOTTLE (71335-2190-1) 2022-11-150000-00-00NoNoCurrent
71335-2190-27133521900260 TABLET, FILM COATED in 1 BOTTLE (71335-2190-2) 2022-11-150000-00-00NoNoCurrent
71335-2190-37133521900320 TABLET, FILM COATED in 1 BOTTLE (71335-2190-3) 2022-11-150000-00-00NoNoCurrent
71335-2190-47133521900490 TABLET, FILM COATED in 1 BOTTLE (71335-2190-4) 2022-11-150000-00-00NoNoCurrent
71335-2190-571335219005100 TABLET, FILM COATED in 1 BOTTLE (71335-2190-5) 2022-11-150000-00-00NoNoCurrent
71335-2190-67133521900610 TABLET, FILM COATED in 1 BOTTLE (71335-2190-6) 2022-11-150000-00-00NoNoCurrent
71335-2190-771335219007120 TABLET, FILM COATED in 1 BOTTLE (71335-2190-7) 2022-11-150000-00-00NoNoCurrent
71335-2190-87133521900850 TABLET, FILM COATED in 1 BOTTLE (71335-2190-8) 2022-11-150000-00-00NoNoCurrent
71335-2190-97133521900914 TABLET, FILM COATED in 1 BOTTLE (71335-2190-9) 2022-11-15NoNoCurrent