Famotidine

Product NDC
68016-801
11-digit product format
680160801
Labeler code
68016
Product ID
68016-801_b45a96e7-fbe0-e686-e75d-1629dd2cda40
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA077367
Marketing category
ANDA
Marketing start
2021-11-01
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
Rxcui199047, 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
68016-801-25Famotidine1 in 1 CARTONTABLET15
68016-801-25Famotidine25 in 1 BOTTLETABLET255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-801FAMOTIDINE TABLET [CHAIN DRUG CONSORTIUM, LLC]4Current NDC, Legacy NDC, 2 package rows20241024_937f7bce-955b-9418-5aed-2e84aee50de3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN937f7bce-955b-9418-5aed-2e84aee50de35
310273famotidine 20 MG Oral TabletPSN937f7bce-955b-9418-5aed-2e84aee50de35
199047famotidine 10 MG Oral TabletSCD937f7bce-955b-9418-5aed-2e84aee50de35
310273famotidine 20 MG Oral TabletSCD937f7bce-955b-9418-5aed-2e84aee50de35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-801-25680160801251 BOTTLE in 1 CARTON (68016-801-25) / 25 TABLET in 1 BOTTLE1 bottle2021-11-010000-00-00NoNoCurrent