FDA.reportPublic FDA data

Famotidine

Product NDC
51655-233
11-digit product format
516550233
Labeler code
51655
Product ID
51655-233_48d2cc09-c2fe-d7c7-e063-6294a90a73a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075511
Marketing category
ANDA
Marketing start
2022-08-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2027-12-31

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
51655-233-25Famotidine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
51655-233-26Famotidine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
51655-233-52Famotidine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-233FAMOTIDINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 3 package rows20230301_f2b6da72-72ea-d81b-e053-2995a90a9526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNf2b6da72-72ea-d81b-e053-2995a90a95262
310273famotidine 20 MG Oral TabletSCDf2b6da72-72ea-d81b-e053-2995a90a95262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-233-255165502332560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-233-25) 2022-12-06NoNoCurrent
51655-233-265165502332690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-233-26) 2022-08-17NoNoCurrent
51655-233-525165502335230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-233-52) 2022-10-05NoNoCurrent