FDA.reportPublic FDA data

Famotidine

Product NDC
49999-237
11-digit product format
499990237
Labeler code
49999
Product ID
49999-237_88b33f8e-7fd6-45d0-8f1d-2479efbdb19f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
49999-237-302021-09-20C16284748780-1ba0f9c33-15cc-a910-e053-dadaa90a0b85Famotidine Tablets USP
49999-237-602021-09-20C16284748780-1ba0f9c33-15cc-a910-e053-dadaa90a0b85Famotidine Tablets USP
49999-237-902021-09-20C16284748780-1ba0f9c33-15cc-a910-e053-dadaa90a0b85Famotidine Tablets USP
49999-237-302021-01-29C16284748780-1ba0f9c33-15cc-a910-e053-dadaa90a0b85Famotidine Tablets USP
49999-237-602021-01-29C16284748780-1ba0f9c33-15cc-a910-e053-dadaa90a0b85Famotidine Tablets USP
49999-237-902021-01-29C16284748780-1ba0f9c33-15cc-a910-e053-dadaa90a0b85Famotidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49999-237-30Famotidine30 in 1 BOTTLETABLET301111777777
49999-237-60Famotidine60 in 1 BOTTLETABLET601111777777

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-237FAMOTIDINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1111777777Legacy NDC, 2 package rows20191023_b85f7b42-3012-4cbb-a805-74ea665636e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNb85f7b42-3012-4cbb-a805-74ea665636e61111777777
310273famotidine 20 MG Oral TabletSCDb85f7b42-3012-4cbb-a805-74ea665636e61111777777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49999-237-304999902373030 in 1 BOTTLEHistorical
49999-237-604999902376060 in 1 BOTTLEHistorical