FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
50090-6582
11-digit product format
500906582
Labeler code
50090
Product ID
50090-6582_19dcbba7-ac41-459f-9a13-3d9426f44f73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215630
Marketing category
ANDA
Marketing start
2022-07-08
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
50090-6582-0FAMOTIDINE30 in 1 BOTTLETABLET, FILM COATED303
50090-6582-1FAMOTIDINE20 in 1 BOTTLETABLET, FILM COATED203
50090-6582-2FAMOTIDINE60 in 1 BOTTLETABLET, FILM COATED603
50090-6582-3FAMOTIDINE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6582-0EA - Each50090-6582d074af2b-b469-469c-8c3a-5836d13495ba12023-09-05
50090-6582-1EA - Each50090-658265c3cbfc-b9f0-4752-8f01-2ce05ea83df412023-09-05
50090-6582-2EA - Each50090-65826ff67819-a4e8-4ecd-a941-751e7973585112023-09-05
50090-6582-3EA - Each50090-6582538b8863-ffa5-4e25-ac45-2f32936c611212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6582FAMOTIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20230816_3c32f8e2-f54a-422d-9c25-68692ea09001.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN3c32f8e2-f54a-422d-9c25-68692ea090013
310273famotidine 20 MG Oral TabletSCD3c32f8e2-f54a-422d-9c25-68692ea090013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6582-05009065820030 TABLET, FILM COATED in 1 BOTTLE (50090-6582-0) 2023-08-09NoNoCurrent
50090-6582-15009065820120 TABLET, FILM COATED in 1 BOTTLE (50090-6582-1) 2023-08-09NoNoCurrent
50090-6582-25009065820260 TABLET, FILM COATED in 1 BOTTLE (50090-6582-2) 2023-08-09NoNoCurrent
50090-6582-35009065820390 TABLET, FILM COATED in 1 BOTTLE (50090-6582-3) 2023-08-09NoNoCurrent