Famotidine

Product NDC
55319-427
11-digit product format
553190427
Labeler code
55319
Product ID
55319-427_7fb4e13d-ec82-e5a6-6cd5-f0f6eebf7635
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar Stores, Inc.
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-427-10Famotidine100 in 1 BOTTLETABLET1003
55319-427-10Famotidine1 in 1 CARTONTABLET13
55319-427-25Famotidine1 in 1 CARTONTABLET13
55319-427-25Famotidine25 in 1 BOTTLETABLET253
55319-427-50Famotidine50 in 1 BOTTLETABLET503
55319-427-50Famotidine1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-427FAMOTIDINE TABLET [FAMILY DOLLAR STORES, INC.]2Current NDC, 6 package rows20241024_0f81e8ac-ddad-13d6-e883-6a5310e058de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN0f81e8ac-ddad-13d6-e883-6a5310e058de3
310273famotidine 20 MG Oral TabletPSN0f81e8ac-ddad-13d6-e883-6a5310e058de3
199047famotidine 10 MG Oral TabletSCD0f81e8ac-ddad-13d6-e883-6a5310e058de3
310273famotidine 20 MG Oral TabletSCD0f81e8ac-ddad-13d6-e883-6a5310e058de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-427-10553190427101 BOTTLE in 1 CARTON (55319-427-10) / 100 TABLET in 1 BOTTLE1 bottle2023-10-01NoNoCurrent
55319-427-25553190427251 BOTTLE in 1 CARTON (55319-427-25) / 25 TABLET in 1 BOTTLE1 bottle2023-10-01NoNoCurrent
55319-427-50553190427501 BOTTLE in 1 CARTON (55319-427-50) / 50 TABLET in 1 BOTTLE1 bottle2023-10-01NoNoCurrent