FDA.reportPublic FDA data

Famotidine

Product NDC
43063-696
11-digit product format
430630696
Labeler code
43063
Product ID
43063-696_4147b115-910a-13aa-e063-6394a90ad9e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-696-30Famotidine30 in 1 BOTTLE, PLASTICTABLET3021
43063-696-90Famotidine90 in 1 BOTTLE, PLASTICTABLET9021
43063-696-93Famotidine180 in 1 BOTTLE, PLASTICTABLET18021
43063-696-95Famotidine1000 in 1 BOTTLE, PLASTICTABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-696-30EA - Each43063-696272a756f-df91-4560-bc1f-8c202c4a3f7812016-09-02
43063-696-60EA - Each43063-696786706d0-4b90-4f46-af5e-f0518c9fffda12016-09-02
43063-696-90EA - Each43063-696bf536ba3-6868-4dfc-b930-1bc641b1a72412016-09-02
43063-696-93EA - Each43063-696209813f4-14e7-4fbd-8364-5cd159c53d2612016-09-02
43063-696-95EA - Each43063-696f2a2a63b-7bf5-47f3-808d-cedb0beb9beb12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-696FAMOTIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 4 package rows20240925_09ef39a4-c6b3-4395-8211-3f551dc44830.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN09ef39a4-c6b3-4395-8211-3f551dc4483021
284245famotidine 40 MG Oral TabletSCD09ef39a4-c6b3-4395-8211-3f551dc4483021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-696-304306306963030 TABLET in 1 BOTTLE, PLASTIC (43063-696-30) 30 tablet2016-07-260000-00-00NoNoCurrent
43063-696-604306306966060 TABLET in 1 BOTTLE, PLASTIC (43063-696-60) 60 tablet2016-07-260000-00-00NoNoCurrent
43063-696-904306306969090 TABLET in 1 BOTTLE, PLASTIC (43063-696-90) 90 tablet2016-07-260000-00-00NoNoCurrent
43063-696-9343063069693180 TABLET in 1 BOTTLE, PLASTIC (43063-696-93) 180 tablet2016-07-260000-00-00NoNoCurrent
43063-696-95430630696951000 TABLET in 1 BOTTLE, PLASTIC (43063-696-95) 1000 tablet2021-05-110000-00-00NoNoCurrent