FDA.reportPublic FDA data

Famotidine

Product NDC
63323-738
11-digit product format
633230738
Labeler code
63323
Product ID
63323-738_14c82153-53c9-4457-8cd3-fbb045885412
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075709
Marketing category
ANDA
Marketing start
2001-07-19
Substance
FAMOTIDINE
Active strength
10 mg/mL
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
FAMOTIDINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui204441

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-738-03Famotidine4 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION46
63323-738-06Famotidine20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION206
63323-738-09Famotidine10 in 1 TRAYINJECTION, SOLUTION106
63323-738-20Famotidine10 in 1 TRAYINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-738-04ML - Milliliter63323-738c72698f4-3e89-481a-9915-d97fcc1d0c2612012-07-24
63323-738-06ML - Milliliter63323-738ebc9ffe6-5e6d-4cca-8741-aedc7644655912021-11-09
63323-738-09ML - Milliliter63323-7387490ccad-99a7-45f4-8296-23639022d1a512013-02-13
63323-738-20ML - Milliliter63323-738f81fc1c0-2897-4dc8-a28b-ce54469f36da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAIFAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AFAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-738FAMOTIDINE (FAMOTIDINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 4 package rows20221027_5995d726-f3f8-4c2d-af19-1b12e3f769c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204441famotidine 10 MG/ML Injectable SolutionPSN5995d726-f3f8-4c2d-af19-1b12e3f769c66
204441famotidine 10 MG/ML Injectable SolutionSCD5995d726-f3f8-4c2d-af19-1b12e3f769c66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-738-03633230738034 mL in 1 VIAL, MULTI-DOSE4 mlHistorical
63323-738-066332307380620 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
63323-738-096332307380910 VIAL, MULTI-DOSE in 1 TRAY (63323-738-09) / 4 mL in 1 VIAL, MULTI-DOSE (63323-738-03) 2001-07-190000-00-00NoNoCurrent
63323-738-206332307382010 VIAL, MULTI-DOSE in 1 TRAY (63323-738-20) / 20 mL in 1 VIAL, MULTI-DOSE (63323-738-06) 2001-07-190000-00-00NoNoCurrent