FDA.reportPublic FDA data

Famotidine

Product NDC
82804-981
11-digit product format
828040981
Labeler code
82804
Product ID
82804-981_7335a9b3-33fb-4343-bc31-b26dd58c0a1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA217669
Marketing category
ANDA
Marketing start
2024-09-09
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
82804-981-00Famotidine100 in 1 BOTTLE, PLASTICTABLET, COATED1002
82804-981-20Famotidine20 in 1 BOTTLE, PLASTICTABLET, COATED202
82804-981-30Famotidine30 in 1 BOTTLE, PLASTICTABLET, COATED302
82804-981-55Famotidine500 in 1 BOTTLE, PLASTICTABLET, COATED5002
82804-981-60Famotidine60 in 1 BOTTLE, PLASTICTABLET, COATED602
82804-981-67Famotidine270 in 1 BOTTLE, PLASTICTABLET, COATED2702
82804-981-72Famotidine120 in 1 BOTTLE, PLASTICTABLET, COATED1202
82804-981-78Famotidine180 in 1 BOTTLE, PLASTICTABLET, COATED1802
82804-981-90Famotidine90 in 1 BOTTLE, PLASTICTABLET, COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-981-00EA - Each82804-9816d7d3529-89e1-4c87-b872-b030fe6f3cd612025-03-04
82804-981-20EA - Each82804-981df880268-db76-48eb-a1f1-021bfee2283412025-03-04
82804-981-30EA - Each82804-981c0c672af-1acb-4b10-b590-222b0c33be0712025-03-04
82804-981-55EA - Each82804-981d73bc097-53cf-4e45-a82c-e1e8e8f1a1f812025-03-04
82804-981-60EA - Each82804-9812bfae40f-244c-467a-90a2-2acf294541c312025-03-04
82804-981-67EA - Each82804-981394c7325-2a53-4112-b562-6b84187afe7812025-03-04
82804-981-72EA - Each82804-98153099a98-9e87-44fd-89c8-2d089b78407612025-03-04
82804-981-78EA - Each82804-981131e3bdc-33b5-4e41-b150-c7c8339825aa12025-03-04
82804-981-90EA - Each82804-981a1c561f8-1e58-48e2-8ae1-21bf74b1976912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-981FAMOTIDINE TABLET, COATED [PROFICIENT RX LP]2Current NDC, 9 package rows20250228_c7327748-835b-44df-848f-8c620d327ce6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNc7327748-835b-44df-848f-8c620d327ce62
284245famotidine 40 MG Oral TabletPSNc7327748-835b-44df-848f-8c620d327ce62
310273famotidine 20 MG Oral TabletSCDc7327748-835b-44df-848f-8c620d327ce62
284245famotidine 40 MG Oral TabletSCDc7327748-835b-44df-848f-8c620d327ce62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-981-0082804098100100 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-00) 2025-01-27NoNoHistorical
82804-981-208280409812020 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-20) 2025-01-27NoNoHistorical
82804-981-308280409813030 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-30) 2025-01-27NoNoHistorical
82804-981-5582804098155500 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-55) 2025-01-27NoNoHistorical
82804-981-608280409816060 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-60) 2025-01-27NoNoHistorical
82804-981-6782804098167270 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-67) 2025-01-27NoNoHistorical
82804-981-7282804098172120 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-72) 2025-01-27NoNoHistorical
82804-981-7882804098178180 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-78) 2025-01-27NoNoHistorical
82804-981-908280409819090 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-981-90) 2025-01-27NoNoHistorical