FDA.reportPublic FDA data

Famotidine

Product NDC
46708-294
11-digit product format
467080294
Labeler code
46708
Product ID
46708-294_02d57009-ba37-4b5d-af59-7a62f1d9e29c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA078916
Marketing category
ANDA
Marketing start
2016-01-29
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, 310273

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-294-10Famotidine100 in 1 CARTONTABLET1004
46708-294-30Famotidine30 in 1 BOTTLETABLET304
46708-294-31Famotidine100 in 1 BOTTLETABLET1004
46708-294-71Famotidine500 in 1 BOTTLETABLET5004
46708-294-91Famotidine1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-294FAMOTIDINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 5 package rows20230129_7c0f3fa5-0a44-4a98-bc43-8bff8e95c462.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN7c0f3fa5-0a44-4a98-bc43-8bff8e95c4624
284245famotidine 40 MG Oral TabletPSN7c0f3fa5-0a44-4a98-bc43-8bff8e95c4624
310273famotidine 20 MG Oral TabletSCD7c0f3fa5-0a44-4a98-bc43-8bff8e95c4624
284245famotidine 40 MG Oral TabletSCD7c0f3fa5-0a44-4a98-bc43-8bff8e95c4624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-294-1046708029410100 TABLET in 1 CARTON (46708-294-10) 100 tablet2016-01-290000-00-00NoNoCurrent
46708-294-304670802943030 TABLET in 1 BOTTLE (46708-294-30) 30 tablet2016-01-290000-00-00NoNoCurrent
46708-294-3146708029431100 TABLET in 1 BOTTLE (46708-294-31) 100 tablet2016-01-290000-00-00NoNoCurrent
46708-294-604670802946060 TABLET in 1 BOTTLE (46708-294-60) 60 tablet2016-01-290000-00-00NoNoCurrent
46708-294-7146708029471500 TABLET in 1 BOTTLE (46708-294-71) 500 tablet2016-01-290000-00-00NoNoCurrent
46708-294-904670802949090 TABLET in 1 BOTTLE (46708-294-90) 90 tablet2016-01-290000-00-00NoNoCurrent
46708-294-91467080294911000 TABLET in 1 BOTTLE (46708-294-91) 1000 tablet2016-01-290000-00-00NoNoCurrent