FDA.reportPublic FDA data

Famotidine

Product NDC
51655-102
11-digit product format
516550102
Labeler code
51655
Product ID
51655-102_46e32413-ef7f-4882-e063-6394a90a78a0
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
2014-08-25
Substance
FAMOTIDINE
Active strength
40 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
FAMOTIDINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui284245

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-102-302023-10-31C16284748780-19d75b9cf-f047-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS . FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986
51655-102-302020-01-31C16284748780-19d75b9cf-f047-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS . FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-102-26Famotidine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
51655-102-30Famotidine30 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-102FAMOTIDINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20231031_03503cd5-bd8e-4bff-b90d-1a71c5225b91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN03503cd5-bd8e-4bff-b90d-1a71c5225b913
284245famotidine 40 MG Oral TabletSCD03503cd5-bd8e-4bff-b90d-1a71c5225b913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-102-265165501022690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-102-26) 2023-01-25NoNoCurrent
51655-102-305165501023030 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-102-30) 2014-08-25NoNoCurrent