FDA.reportPublic FDA data

Famotidine

Product NDC
82804-980
11-digit product format
828040980
Labeler code
82804
Product ID
82804-980_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
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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-980-00Famotidine100 in 1 BOTTLE, PLASTICTABLET, COATED1002
82804-980-20Famotidine20 in 1 BOTTLE, PLASTICTABLET, COATED202
82804-980-30Famotidine30 in 1 BOTTLE, PLASTICTABLET, COATED302
82804-980-55Famotidine500 in 1 BOTTLE, PLASTICTABLET, COATED5002
82804-980-60Famotidine60 in 1 BOTTLE, PLASTICTABLET, COATED602
82804-980-67Famotidine270 in 1 BOTTLE, PLASTICTABLET, COATED2702
82804-980-72Famotidine120 in 1 BOTTLE, PLASTICTABLET, COATED1202
82804-980-78Famotidine180 in 1 BOTTLE, PLASTICTABLET, COATED1802
82804-980-90Famotidine90 in 1 BOTTLE, PLASTICTABLET, COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-980FAMOTIDINE 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
82804-980-0082804098000100 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-00) 2025-01-27NoNoCurrent
82804-980-208280409802020 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-20) 2025-01-27NoNoCurrent
82804-980-308280409803030 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-30) 2025-01-27NoNoCurrent
82804-980-5582804098055500 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-55) 2025-01-27NoNoCurrent
82804-980-608280409806060 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-60) 2025-01-27NoNoCurrent
82804-980-6782804098067270 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-67) 2025-01-27NoNoCurrent
82804-980-7282804098072120 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-72) 2025-01-27NoNoCurrent
82804-980-7882804098078180 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-78) 2025-01-27NoNoCurrent
82804-980-908280409809090 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-980-90) 2025-01-27NoNoCurrent