FDA.reportPublic FDA data

Famotidine

Product NDC
70710-1683
11-digit product format
707101683
Labeler code
70710
Product ID
70710-1683_5a3e9c70-b8f8-4866-b128-9f50272c03c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA216441
Marketing category
ANDA
Marketing start
2022-06-06
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
70710-1683-0Famotidine1000 in 1 BOTTLETABLET, FILM COATED10002
70710-1683-1Famotidine100 in 1 BOTTLETABLET, FILM COATED1002
70710-1683-2Famotidine10 in 1 BLISTER PACKTABLET, FILM COATED102
70710-1683-3Famotidine30 in 1 BOTTLETABLET, FILM COATED302
70710-1683-4Famotidine10 in 1 CARTONTABLET, FILM COATED102
70710-1683-5Famotidine500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1683FAMOTIDINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 6 package rows20231011_b165979b-7ed0-423e-9aeb-2e061df0cd45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN72a97532-9a79-4cbf-b9d0-22ce1f21468d104
310273famotidine 20 MG Oral TabletSCD72a97532-9a79-4cbf-b9d0-22ce1f21468d104
310273famotidine 20 MG Oral TabletPSNb165979b-7ed0-423e-9aeb-2e061df0cd452
310273famotidine 20 MG Oral TabletPSNea643663-5ec5-fdc0-e053-2995a90a8f972
284245famotidine 40 MG Oral TabletPSNb165979b-7ed0-423e-9aeb-2e061df0cd452
310273famotidine 20 MG Oral TabletSCDb165979b-7ed0-423e-9aeb-2e061df0cd452
310273famotidine 20 MG Oral TabletSCDea643663-5ec5-fdc0-e053-2995a90a8f972
284245famotidine 40 MG Oral TabletSCDb165979b-7ed0-423e-9aeb-2e061df0cd452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1683-0707101683001000 TABLET, FILM COATED in 1 BOTTLE (70710-1683-0) 2022-06-060000-00-00NoNoCurrent
70710-1683-170710168301100 TABLET, FILM COATED in 1 BOTTLE (70710-1683-1) 2022-06-060000-00-00NoNoCurrent
70710-1683-27071016830210 in 1 BLISTER PACKHistorical
70710-1683-37071016830330 TABLET, FILM COATED in 1 BOTTLE (70710-1683-3) 2022-06-060000-00-00NoNoCurrent
70710-1683-47071016830410 BLISTER PACK in 1 CARTON (70710-1683-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1683-2) 10 blister pack2022-06-060000-00-00NoNoCurrent
70710-1683-570710168305500 TABLET, FILM COATED in 1 BOTTLE (70710-1683-5) 2022-06-060000-00-00NoNoCurrent