famotidine

Product NDC
62135-808
11-digit product format
621350808
Labeler code
62135
Product ID
62135-808_42c9eb63-96d0-3757-e063-6394a90ad58f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA075786
Marketing category
ANDA
Marketing start
2020-09-23
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
62135-808-90famotidine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-808-90EA - Each62135-808e7c7ea22-ee43-4bee-af54-7d715a9cf40312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-808FAMOTIDINE TABLET, FILM COATED [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241030_70714491-1368-4824-98af-03fda52139a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN70714491-1368-4824-98af-03fda52139a93
284245famotidine 40 MG Oral TabletPSN70714491-1368-4824-98af-03fda52139a93
310273famotidine 20 MG Oral TabletSCD70714491-1368-4824-98af-03fda52139a93
284245famotidine 40 MG Oral TabletSCD70714491-1368-4824-98af-03fda52139a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-808-906213508089090 TABLET, FILM COATED in 1 BOTTLE (62135-808-90) 2023-12-08NoNoCurrent