FDA.reportPublic FDA data

Famotidine

Product NDC
68094-054
11-digit product format
680940054
Labeler code
68094
Product ID
68094-054_85fb9c19-0c02-4c0e-8f80-ecead1578723
Type
HUMAN OTC DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA077351
Marketing category
ANDA
Marketing start
2024-03-28
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
Rxcui310273

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
68094-054-59Famotidine10 in 1 BLISTER PACKTABLET, FILM COATED103
68094-054-65Famotidine20 in 1 CARTONTABLET, FILM COATED203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-054-59EA - Each68094-054258b3962-13df-489e-ab50-4f4b39ca27a812024-05-16
68094-054-65EA - Each68094-054f69c2c4f-0bb4-41f4-8503-ae7a758f0b3612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-054FAMOTIDINE TABLET, FILM COATED [PRECISION DOSE, INC.]3Current NDC, 2 package rows20250529_de42b6c4-c44b-4ec1-b505-fc5266452d57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNde42b6c4-c44b-4ec1-b505-fc5266452d573
310273famotidine 20 MG Oral TabletSCDde42b6c4-c44b-4ec1-b505-fc5266452d573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-054-596809400545910 in 1 BLISTER PACKHistorical
68094-054-656809400546520 BLISTER PACK in 1 CARTON (68094-054-65) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-054-59) 20 blister pack2024-03-28NoNoHistorical