FDA.reportPublic FDA data

Famotidine

Product NDC
51655-312
11-digit product format
516550312
Labeler code
51655
Product ID
51655-312_48eaefc6-3b41-0111-e063-6294a90abbd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075805
Marketing category
ANDA
Marketing start
2020-05-21
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-312-202023-04-18C16284748780-1f386c649-c4e5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
51655-312-252023-04-18C16284748780-1f386c649-c4e5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
51655-312-202023-01-30C16284748780-1f386c649-c4e5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
51655-312-252023-01-30C16284748780-1f386c649-c4e5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-312-20Famotidine20 in 1 BOTTLE, PLASTICTABLET205
51655-312-25Famotidine60 in 1 BOTTLE, PLASTICTABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-312FAMOTIDINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20250101_ab1cdbbf-d838-020c-e053-2995a90a0f65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNab1cdbbf-d838-020c-e053-2995a90a0f655
310273famotidine 20 MG Oral TabletSCDab1cdbbf-d838-020c-e053-2995a90a0f655

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-312-205165503122020 TABLET in 1 BOTTLE, PLASTIC (51655-312-20) 20 tablet2020-05-220000-00-00NoNoCurrent
51655-312-255165503122560 TABLET in 1 BOTTLE, PLASTIC (51655-312-25) 60 tablet2020-05-210000-00-00NoNoCurrent