FDA.reportPublic FDA data

Famotidine

Product NDC
72205-145
11-digit product format
722050145
Labeler code
72205
Product ID
72205-145_34acb853-6632-49cd-970a-e6fd840852d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217400
Marketing category
ANDA
Marketing start
2024-08-06
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
72205-145-05Famotidine500 in 1 BOTTLETABLET, FILM COATED5002
72205-145-30Famotidine30 in 1 BOTTLETABLET, FILM COATED302
72205-145-50Famotidine50 in 1 BOTTLETABLET, FILM COATED502
72205-145-91Famotidine100 in 1 BOTTLETABLET, FILM COATED1002
72205-145-98Famotidine75 in 1 BOTTLETABLET, FILM COATED752
72205-145-99Famotidine1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-145-05EA - Each72205-1454fb0618f-74a5-4f59-8210-cb4627c6c84312025-02-10
72205-145-30EA - Each72205-1450182f562-c049-48cd-b719-7cfe6b7a796d12025-02-10
72205-145-91EA - Each72205-14512d2f78c-9eb9-4e08-9274-5ae09a55101312025-02-10
72205-145-99EA - Each72205-145c841f6ff-c204-4564-96bb-8d67908c1e8b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-145FAMOTIDINE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 6 package rows20240920_74a24590-a0b6-4607-8e67-9fadce53389b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN8dbf43e0-856f-443b-b8a4-c69e006878ea3
310273famotidine 20 MG Oral TabletSCD8dbf43e0-856f-443b-b8a4-c69e006878ea3
310273famotidine 20 MG Oral TabletPSN74a24590-a0b6-4607-8e67-9fadce53389b2
284245famotidine 40 MG Oral TabletPSN74a24590-a0b6-4607-8e67-9fadce53389b2
310273famotidine 20 MG Oral TabletSCD74a24590-a0b6-4607-8e67-9fadce53389b2
284245famotidine 40 MG Oral TabletSCD74a24590-a0b6-4607-8e67-9fadce53389b2
310273famotidine 20 MG Oral TabletPSN44f3f63d-4522-91e4-e063-6394a90a6d1b1
310273famotidine 20 MG Oral TabletPSN6edbd842-cf86-48a5-bc22-967620a2b5cb1
310273famotidine 20 MG Oral TabletPSNc133a9e1-ca48-4ee2-8768-01f44f5dd5111
310273famotidine 20 MG Oral TabletSCD44f3f63d-4522-91e4-e063-6394a90a6d1b1
310273famotidine 20 MG Oral TabletSCD6edbd842-cf86-48a5-bc22-967620a2b5cb1
310273famotidine 20 MG Oral TabletSCDc133a9e1-ca48-4ee2-8768-01f44f5dd5111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-145-0572205014505500 TABLET, FILM COATED in 1 BOTTLE (72205-145-05) 2024-09-18NoNoCurrent
72205-145-307220501453030 TABLET, FILM COATED in 1 BOTTLE (72205-145-30) 2024-09-18NoNoCurrent
72205-145-507220501455050 TABLET, FILM COATED in 1 BOTTLE (72205-145-50) 2025-11-12NoNoCurrent
72205-145-9172205014591100 TABLET, FILM COATED in 1 BOTTLE (72205-145-91) 2024-09-18NoNoCurrent
72205-145-987220501459875 TABLET, FILM COATED in 1 BOTTLE (72205-145-98) 2025-11-12NoNoCurrent
72205-145-99722050145991000 TABLET, FILM COATED in 1 BOTTLE (72205-145-99) 2024-09-18NoNoCurrent