FDA.reportPublic FDA data

Famotidine

Product NDC
71205-535
11-digit product format
712050535
Labeler code
71205
Product ID
71205-535_37ca9d4f-3fed-421a-a18f-a9954c00a90c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206530
Marketing category
ANDA
Marketing start
2015-12-22
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
71205-535-06Famotidine6 in 1 BOTTLETABLET, FILM COATED64
71205-535-10Famotidine10 in 1 BOTTLETABLET, FILM COATED104
71205-535-30Famotidine30 in 1 BOTTLETABLET, FILM COATED304
71205-535-60Famotidine60 in 1 BOTTLETABLET, FILM COATED604
71205-535-78Famotidine180 in 1 BOTTLETABLET, FILM COATED1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-535-06EA - Each71205-5357cebc4eb-4b48-44d3-90d3-c387f99d9e5712021-04-08
71205-535-10EA - Each71205-535cd86635c-beea-49a1-901a-8af3387ceeaa12021-10-08
71205-535-30EA - Each71205-535ebaff6cb-dae3-460b-95a9-7ecb59633a1b12021-04-08
71205-535-60EA - Each71205-53574540fc5-d3b0-48ce-832e-c8d9d6bb7f7b12021-06-02
71205-535-78EA - Each71205-535d13505b7-7ff7-4c76-98c3-7c78b2298a0112024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-535FAMOTIDINE TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20240907_4adb4864-04ac-4cb1-96c2-6196a30ac640.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN4adb4864-04ac-4cb1-96c2-6196a30ac6404
310273famotidine 20 MG Oral TabletSCD4adb4864-04ac-4cb1-96c2-6196a30ac6404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-535-06712050535066 TABLET, FILM COATED in 1 BOTTLE (71205-535-06) 2021-02-240000-00-00NoNoCurrent
71205-535-107120505351010 TABLET, FILM COATED in 1 BOTTLE (71205-535-10) 2021-02-240000-00-00NoNoCurrent
71205-535-307120505353030 TABLET, FILM COATED in 1 BOTTLE (71205-535-30) 2021-02-160000-00-00NoNoCurrent
71205-535-607120505356060 TABLET, FILM COATED in 1 BOTTLE (71205-535-60) 2021-02-160000-00-00NoNoCurrent
71205-535-7871205053578180 TABLET, FILM COATED in 1 BOTTLE (71205-535-78) 2024-09-06NoNoCurrent
71205-535-907120505359090 TABLET, FILM COATED in 1 BOTTLE (71205-535-90) 2021-02-160000-00-00NoNoCurrent