FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
67877-843
11-digit product format
678770843
Labeler code
67877
Product ID
67877-843_ea50552f-f9b9-467f-a925-62ff027df607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA215630
Marketing category
ANDA
Marketing start
2022-07-08
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
67877-843-01FAMOTIDINE100 in 1 BOTTLETABLET, FILM COATED1001
67877-843-05FAMOTIDINE500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-843-01EA - Each67877-8432664fc51-a8fe-43a5-a600-3751d5c725fc12022-08-04
67877-843-05EA - Each67877-843198cfe40-9dd7-4610-a170-f5046f3089bb12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-843FAMOTIDINE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]1Current NDC, Legacy NDC, 2 package rows20230826_ea50552f-f9b9-467f-a925-62ff027df607.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSN077bb160-e616-4863-bdde-989140f99e1c102
284245famotidine 40 MG Oral TabletSCD077bb160-e616-4863-bdde-989140f99e1c102
284245famotidine 40 MG Oral TabletPSNa3b50576-cd40-4f7e-9506-bd0a619884244
284245famotidine 40 MG Oral TabletPSNdbf94314-3a34-4f03-80b1-296559b7d6a54
284245famotidine 40 MG Oral TabletSCDa3b50576-cd40-4f7e-9506-bd0a619884244
284245famotidine 40 MG Oral TabletSCDdbf94314-3a34-4f03-80b1-296559b7d6a54
284245famotidine 40 MG Oral TabletPSNfc603d56-6828-8c5e-e053-6394a90a35bd3
284245famotidine 40 MG Oral TabletSCDfc603d56-6828-8c5e-e053-6394a90a35bd3
284245famotidine 40 MG Oral TabletPSNfebe39b1-9212-a281-e053-6394a90a1a9f2
284245famotidine 40 MG Oral TabletSCDfebe39b1-9212-a281-e053-6394a90a1a9f2
284245famotidine 40 MG Oral TabletPSNea50552f-f9b9-467f-a925-62ff027df6071
284245famotidine 40 MG Oral TabletSCDea50552f-f9b9-467f-a925-62ff027df6071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-843-0167877084301100 TABLET, FILM COATED in 1 BOTTLE (67877-843-01) 2022-07-080000-00-00NoNoCurrent
67877-843-0567877084305500 TABLET, FILM COATED in 1 BOTTLE (67877-843-05) 2022-07-080000-00-00NoNoCurrent