Famotidine

Product NDC
68071-4197
11-digit product format
680714197
Labeler code
68071
Product ID
68071-4197_1a3b98e7-ec70-569d-e063-6394a90a4470
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4197-3Famotidine30 in 1 BOTTLETABLET305
68071-4197-6Famotidine60 in 1 BOTTLETABLET605
68071-4197-9Famotidine90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4197FAMOTIDINE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240608_60cd0973-f74e-2b70-e053-2a91aa0a4361.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN60cd0973-f74e-2b70-e053-2a91aa0a43615
284245famotidine 40 MG Oral TabletSCD60cd0973-f74e-2b70-e053-2a91aa0a43615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4197-36807141970330 TABLET in 1 BOTTLE (68071-4197-3) 30 tablet2017-12-200000-00-00NoNoCurrent
68071-4197-66807141970660 TABLET in 1 BOTTLE (68071-4197-6) 60 tablet2017-12-200000-00-00NoNoCurrent
68071-4197-96807141970990 TABLET in 1 BOTTLE (68071-4197-9) 90 tablet2017-12-200000-00-00NoNoCurrent