FDA.reportPublic FDA data

Famotidine

Product NDC
0904-7193
11-digit product format
009047193
Labeler code
0904
Product ID
0904-7193_4c695403-dfaa-4d38-8dc5-f463e76abeaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075718
Marketing category
ANDA
Marketing start
2001-04-16
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
Rxcui310273

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
0904-7193-06Famotidine1 in 1 BLISTER PACKTABLET, FILM COATED14
0904-7193-06Famotidine50 in 1 CARTONTABLET, FILM COATED504
0904-7193-61Famotidine1 in 1 BLISTER PACKTABLET, FILM COATED14
0904-7193-61Famotidine100 in 1 CARTONTABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7193-06EA - Each0904-7193a257585b-541b-4688-9f45-42ca391841a012022-10-06
0904-7193-61EA - Each0904-71935f8bcfed-c786-47fa-9ee4-27ef6d2ee07412022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7193FAMOTIDINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 4 package rows20241020_3e6d167f-91e4-4122-911d-d3da66386f44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN5d515c2a-dac9-42d8-aede-66d28a427dbc5
310273famotidine 20 MG Oral TabletSCD5d515c2a-dac9-42d8-aede-66d28a427dbc5
310273famotidine 20 MG Oral TabletPSN3e6d167f-91e4-4122-911d-d3da66386f444
310273famotidine 20 MG Oral TabletPSNcdd5dfb7-4efb-4235-8023-5ce145c090384
310273famotidine 20 MG Oral TabletSCD3e6d167f-91e4-4122-911d-d3da66386f444
310273famotidine 20 MG Oral TabletSCDcdd5dfb7-4efb-4235-8023-5ce145c090384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7193-060090471930650 BLISTER PACK in 1 CARTON (0904-7193-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2022-08-100000-00-00NoNoCurrent
0904-7193-6100904719361100 BLISTER PACK in 1 CARTON (0904-7193-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2001-04-160000-00-00NoNoCurrent