FDA.reportPublic FDA data

Famotidine

Product NDC
50090-1045
11-digit product format
500901045
Labeler code
50090
Product ID
50090-1045_e986389d-aee4-4a86-b3f2-8e247ff4a890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075805
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
Rxcui284245, 310273

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
50090-1045-0Famotidine30 in 1 BOTTLETABLET3022
50090-1045-1Famotidine20 in 1 BOTTLETABLET2022
50090-1045-2Famotidine60 in 1 BOTTLETABLET6022
50090-1045-3Famotidine90 in 1 BOTTLETABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1045-0EA - Each50090-10450f553503-90eb-43fe-adff-0f284c4791c012018-11-06
50090-1045-1EA - Each50090-1045c6cf67f7-23ae-4cf8-8b46-544989f0524212018-11-06
50090-1045-2EA - Each50090-1045d0c7d632-a8f8-4dfe-9e1f-5743f0b07de812018-11-06
50090-1045-3EA - Each50090-10458cfb7ffd-1069-41a9-8f18-ac059bd93b5312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1045FAMOTIDINE TABLET [A-S MEDICATION SOLUTIONS]22Current NDC, Legacy NDC, 4 package rows20231026_ae3646c7-76fc-473d-b20b-67d3c6ac0b75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNae3646c7-76fc-473d-b20b-67d3c6ac0b7522
284245famotidine 40 MG Oral TabletPSNae3646c7-76fc-473d-b20b-67d3c6ac0b7522
310273famotidine 20 MG Oral TabletSCDae3646c7-76fc-473d-b20b-67d3c6ac0b7522
284245famotidine 40 MG Oral TabletSCDae3646c7-76fc-473d-b20b-67d3c6ac0b7522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1045-05009010450030 TABLET in 1 BOTTLE (50090-1045-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-1045-15009010450120 TABLET in 1 BOTTLE (50090-1045-1) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-1045-25009010450260 TABLET in 1 BOTTLE (50090-1045-2) 60 tablet2014-11-280000-00-00NoNoCurrent
50090-1045-35009010450390 TABLET in 1 BOTTLE (50090-1045-3) 90 tablet2018-03-120000-00-00NoNoCurrent