FDA.reportPublic FDA data

Famotidine

Product NDC
70771-1703
11-digit product format
707711703
Labeler code
70771
Product ID
70771-1703_33e9f14f-e971-4fbb-9912-991661ae4d05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA216441
Marketing category
ANDA
Marketing start
2022-06-06
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
70771-1703-0Famotidine1000 in 1 BOTTLETABLET, FILM COATED10003
70771-1703-1Famotidine100 in 1 BOTTLETABLET, FILM COATED1003
70771-1703-2Famotidine10 in 1 BLISTER PACKTABLET, FILM COATED103
70771-1703-3Famotidine30 in 1 BOTTLETABLET, FILM COATED303
70771-1703-4Famotidine10 in 1 CARTONTABLET, FILM COATED103
70771-1703-5Famotidine500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1703FAMOTIDINE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 6 package rows20241201_8c17f9e3-9827-4bf9-85ca-72e08a8518ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN8c17f9e3-9827-4bf9-85ca-72e08a8518ca3
284245famotidine 40 MG Oral TabletPSN8c17f9e3-9827-4bf9-85ca-72e08a8518ca3
310273famotidine 20 MG Oral TabletSCD8c17f9e3-9827-4bf9-85ca-72e08a8518ca3
284245famotidine 40 MG Oral TabletSCD8c17f9e3-9827-4bf9-85ca-72e08a8518ca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1703-0707711703001000 TABLET, FILM COATED in 1 BOTTLE (70771-1703-0) 2022-06-060000-00-00NoNoCurrent
70771-1703-170771170301100 TABLET, FILM COATED in 1 BOTTLE (70771-1703-1) 2022-06-060000-00-00NoNoCurrent
70771-1703-27077117030210 in 1 BLISTER PACKHistorical
70771-1703-37077117030330 TABLET, FILM COATED in 1 BOTTLE (70771-1703-3) 2022-06-060000-00-00NoNoCurrent
70771-1703-47077117030410 BLISTER PACK in 1 CARTON (70771-1703-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1703-2) 10 blister pack2022-06-060000-00-00NoNoCurrent
70771-1703-570771170305500 TABLET, FILM COATED in 1 BOTTLE (70771-1703-5) 2022-06-060000-00-00NoNoCurrent