FDA.reportPublic FDA data

Famotidine

Product NDC
72205-146
11-digit product format
722050146
Labeler code
72205
Product ID
72205-146_34acb853-6632-49cd-970a-e6fd840852d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217400
Marketing category
ANDA
Marketing start
2024-08-06
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, 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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-146-05Famotidine500 in 1 BOTTLETABLET, FILM COATED5002
72205-146-30Famotidine30 in 1 BOTTLETABLET, FILM COATED302
72205-146-91Famotidine100 in 1 BOTTLETABLET, FILM COATED1002
72205-146-99Famotidine1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-146-05EA - Each72205-1463f75a610-a0af-4028-9eec-eb90bdf6506d12025-02-10
72205-146-30EA - Each72205-146bb341beb-e8c5-47b1-8098-24c7bb67b52512025-02-10
72205-146-91EA - Each72205-146e3e3604b-7c27-403f-9030-8e6f90ed467b12025-02-10
72205-146-99EA - Each72205-14693e5cd55-132b-4fc8-8ae6-0ecab445eac612025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-146FAMOTIDINE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 4 package rows20240920_74a24590-a0b6-4607-8e67-9fadce53389b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN74a24590-a0b6-4607-8e67-9fadce53389b2
284245famotidine 40 MG Oral TabletPSN74a24590-a0b6-4607-8e67-9fadce53389b2
310273famotidine 20 MG Oral TabletSCD74a24590-a0b6-4607-8e67-9fadce53389b2
284245famotidine 40 MG Oral TabletSCD74a24590-a0b6-4607-8e67-9fadce53389b2
284245famotidine 40 MG Oral TabletPSN669fbd46-cae5-4477-884e-8eca893d2e051
284245famotidine 40 MG Oral TabletSCD669fbd46-cae5-4477-884e-8eca893d2e051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-146-0572205014605500 TABLET, FILM COATED in 1 BOTTLE (72205-146-05) 2024-09-18NoNoCurrent
72205-146-307220501463030 TABLET, FILM COATED in 1 BOTTLE (72205-146-30) 2024-09-18NoNoCurrent
72205-146-9172205014691100 TABLET, FILM COATED in 1 BOTTLE (72205-146-91) 2024-09-18NoNoCurrent
72205-146-99722050146991000 TABLET, FILM COATED in 1 BOTTLE (72205-146-99) 2024-09-18NoNoCurrent