FDA.reportPublic FDA data

Famotidine

Product NDC
0615-8558
11-digit product format
006158558
Labeler code
0615
Product ID
0615-8558_20739b19-9f06-4e88-962e-d812086fdc90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA078916
Marketing category
ANDA
Marketing start
2016-01-29
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
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
FAMOTIDINE20 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
0615-8558-05Famotidine15 in 1 BLISTER PACKTABLET151
0615-8558-28Famotidine28 in 1 BLISTER PACKTABLET281
0615-8558-39Famotidine30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8558FAMOTIDINE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, 3 package rows20250223_59b17677-d805-4d9e-9c64-96385ae47bff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN59b17677-d805-4d9e-9c64-96385ae47bff1
284245famotidine 40 MG Oral TabletPSN59b17677-d805-4d9e-9c64-96385ae47bff1
310273famotidine 20 MG Oral TabletSCD59b17677-d805-4d9e-9c64-96385ae47bff1
284245famotidine 40 MG Oral TabletSCD59b17677-d805-4d9e-9c64-96385ae47bff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8558-050061585580515 TABLET in 1 BLISTER PACK (0615-8558-05) 15 tablet2025-01-16NoNoHistorical
0615-8558-280061585582828 TABLET in 1 BLISTER PACK (0615-8558-28) 28 tablet2025-01-16NoNoHistorical
0615-8558-390061585583930 TABLET in 1 BLISTER PACK (0615-8558-39) 30 tablet2025-01-16NoNoHistorical