Famotidine

Product NDC
69367-401
11-digit product format
693670401
Labeler code
69367
Product ID
69367-401_497a1a19-03b2-4e3d-b5c7-0b94a29b9cc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA217669
Marketing category
ANDA
Marketing start
2024-09-09
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
69367-401-10Famotidine1000 in 1 BOTTLE, PLASTICTABLET, COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-401-10EA - Each69367-40173eb9d76-2908-4dcd-a1c4-4848f0be71a012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-401FAMOTIDINE TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC]5Current NDC, 1 package rows20250409_c0e15f57-ab20-4030-b1d1-6aff33be7d76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNc0e15f57-ab20-4030-b1d1-6aff33be7d765
284245famotidine 40 MG Oral TabletPSNc0e15f57-ab20-4030-b1d1-6aff33be7d765
310273famotidine 20 MG Oral TabletSCDc0e15f57-ab20-4030-b1d1-6aff33be7d765
284245famotidine 40 MG Oral TabletSCDc0e15f57-ab20-4030-b1d1-6aff33be7d765
310273famotidine 20 MG Oral TabletPSNc7327748-835b-44df-848f-8c620d327ce62
284245famotidine 40 MG Oral TabletPSNc7327748-835b-44df-848f-8c620d327ce62
310273famotidine 20 MG Oral TabletSCDc7327748-835b-44df-848f-8c620d327ce62
284245famotidine 40 MG Oral TabletSCDc7327748-835b-44df-848f-8c620d327ce62
284245famotidine 40 MG Oral TabletPSN702dd4fa-4a78-454d-91c5-493894750f7b1
284245famotidine 40 MG Oral TabletSCD702dd4fa-4a78-454d-91c5-493894750f7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-401-10693670401101000 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-401-10) 2024-09-09NoNoCurrent