FDA.reportPublic FDA data

Famotidine

Product NDC
71205-257
11-digit product format
712050257
Labeler code
71205
Product ID
71205-257_1e2003d4-09a3-4cc8-af3d-93d29b9123c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
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

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-257-30Famotidine30 in 1 BOTTLETABLET301
71205-257-60Famotidine60 in 1 BOTTLETABLET601
71205-257-90Famotidine90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-257-30EA - Each71205-2570f22f3da-08a0-4819-b984-246c929cd18d12020-08-06
71205-257-90EA - Each71205-25734fabbef-67c3-43a8-98b7-45ae9185132812020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-257FAMOTIDINE TABLET [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20200730_1e2003d4-09a3-4cc8-af3d-93d29b9123c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN1e2003d4-09a3-4cc8-af3d-93d29b9123c01
284245famotidine 40 MG Oral TabletSCD1e2003d4-09a3-4cc8-af3d-93d29b9123c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-257-307120502573030 TABLET in 1 BOTTLE (71205-257-30) 30 tablet2020-07-230000-00-00NoNoCurrent
71205-257-607120502576060 TABLET in 1 BOTTLE (71205-257-60) 60 tablet2020-07-230000-00-00NoNoCurrent
71205-257-907120502579090 TABLET in 1 BOTTLE (71205-257-90) 90 tablet2020-07-230000-00-00NoNoCurrent