FDA.reportPublic FDA data

Famotidine

Product NDC
50090-1044
11-digit product format
500901044
Labeler code
50090
Product ID
50090-1044_57e5f9b5-17f5-4bf8-b131-20615ef5191a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075511
Marketing category
ANDA
Marketing start
2001-04-16
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
50090-1044-0Famotidine30 in 1 BOTTLETABLET, FILM COATED305
50090-1044-1Famotidine20 in 1 BOTTLETABLET, FILM COATED205
50090-1044-2Famotidine60 in 1 BOTTLETABLET, FILM COATED605
50090-1044-3Famotidine90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1044-0EA - Each50090-1044a64dbd83-1980-479d-b78e-eb68886aaeec12023-09-05
50090-1044-1EA - Each50090-1044aae90c63-3bbd-4967-bafa-9e292eecc55b12023-09-05
50090-1044-2EA - Each50090-10447b294043-5109-4bf7-b09b-7430dd738f6b12023-09-05
50090-1044-3EA - Each50090-1044d3d1d842-fa57-41f8-90f6-537223b8f20c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1044FAMOTIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 4 package rows20230810_74ff64f2-d882-411f-bac8-29dfa4cb4f10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN74ff64f2-d882-411f-bac8-29dfa4cb4f105
310273famotidine 20 MG Oral TabletSCD74ff64f2-d882-411f-bac8-29dfa4cb4f105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1044-05009010440030 TABLET, FILM COATED in 1 BOTTLE (50090-1044-0) 2014-11-280000-00-00NoNoCurrent
50090-1044-15009010440120 TABLET, FILM COATED in 1 BOTTLE (50090-1044-1) 2014-11-280000-00-00NoNoCurrent
50090-1044-25009010440260 TABLET, FILM COATED in 1 BOTTLE (50090-1044-2) 2014-11-280000-00-00NoNoCurrent
50090-1044-35009010440390 TABLET, FILM COATED in 1 BOTTLE (50090-1044-3) 2018-10-050000-00-00NoNoCurrent