FDA.reportPublic FDA data

Famotidine

Product NDC
0832-6045
11-digit product format
008326045
Labeler code
0832
Product ID
0832-6045_266982a6-6b63-69ae-e063-6394a90af64a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA217655
Marketing category
ANDA
Marketing start
2023-06-16
Substance
FAMOTIDINE
Active strength
40 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310274

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
0832-6045-10Famotidine100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005
0832-6045-15Famotidine150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1505
0832-6045-50Famotidine50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-6045-10ML - Milliliter0832-60451cbced43-960c-45c7-93a3-c5fcb08cac5712023-12-05
0832-6045-15ML - Milliliter0832-604525298c90-1f3d-443d-97b7-96343237c32612023-12-05
0832-6045-50ML - Milliliter0832-604533d287e1-62ee-4c47-b8e1-fd723bd8872612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-6045FAMOTIDINE POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, LLC]5Current NDC, 3 package rows20241109_d528fadf-316f-4fea-9bec-070c01f80d64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310274famotidine 40 MG in 5 mL Oral SuspensionPSNd528fadf-316f-4fea-9bec-070c01f80d645
310274famotidine 8 MG/ML Oral SuspensionSCDd528fadf-316f-4fea-9bec-070c01f80d645
310274famotidine 40 MG per 5 ML Oral SuspensionSYd528fadf-316f-4fea-9bec-070c01f80d645

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0832-6045-1000832604510100 mL in 1 BOTTLE (0832-6045-10) 100 ml2023-10-27NoNoCurrent
0832-6045-1500832604515150 mL in 1 BOTTLE (0832-6045-15) 150 ml2023-10-27NoNoCurrent
0832-6045-500083260455050 mL in 1 BOTTLE (0832-6045-50) 50 ml2023-07-11NoNoCurrent