FDA.reportPublic FDA data

Famotidine

Product NDC
63323-739
11-digit product format
633230739
Labeler code
63323
Product ID
63323-739_241710d5-bcef-4852-a09c-0e681250e6aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075813
Marketing category
ANDA
Marketing start
2001-03-15
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
Rxcui1743833

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
63323-739-16Famotidine25 in 1 TRAYINJECTION, SOLUTION257
63323-739-41Famotidine2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION27
63323-739-11Famotidine2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26
63323-739-12Famotidine25 in 1 TRAYINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-739-12ML - Milliliter63323-73974793723-25b7-47ca-85fd-55f10754f44212012-07-24
63323-739-16ML - Milliliter63323-739dea01bc8-4698-4e8a-b7fc-dcae793097e912015-09-10
63323-739-41ML - Milliliter63323-7397deeac44-e43c-40d5-b6b8-93ccf5eb813312024-08-12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-739FAMOTIDINE (FAMOTIDINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20210813_ce533636-cc9b-45d0-87a6-5390377ff28a.zip
63323-739FAMOTIDINE (FAMOTIDINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20221110_aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743833famotidine 20 MG in 2 ML InjectionPSNce533636-cc9b-45d0-87a6-5390377ff28a7
17438332 ML famotidine 10 MG/ML InjectionSCDce533636-cc9b-45d0-87a6-5390377ff28a7
1743833famotidine 20 MG per 2 ML InjectionSYce533636-cc9b-45d0-87a6-5390377ff28a7
1743833famotidine 20 MG in 2 ML InjectionPSNaeb27cea-1ff7-4a6e-93f1-d4c4dac5faa76
17438332 ML famotidine 10 MG/ML InjectionSCDaeb27cea-1ff7-4a6e-93f1-d4c4dac5faa76
1743833famotidine 20 MG per 2 ML InjectionSYaeb27cea-1ff7-4a6e-93f1-d4c4dac5faa76
1743833famotidine 20 MG in 2 ML InjectionPSN9948991d-9405-c7c8-e053-2995a90a60ca3
17438332 ML famotidine 10 MG/ML InjectionSCD9948991d-9405-c7c8-e053-2995a90a60ca3
1743833famotidine 20 MG per 2 ML InjectionSY9948991d-9405-c7c8-e053-2995a90a60ca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-739-11633230739112 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-739-126332307391225 VIAL, SINGLE-DOSE in 1 TRAY (63323-739-12) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-739-11) 2001-03-150000-00-00NoNoCurrent
63323-739-166332307391625 VIAL, SINGLE-USE in 1 TRAY (63323-739-16) / 2 mL in 1 VIAL, SINGLE-USE (63323-739-41) 2001-03-150000-00-00NoNoCurrent
63323-739-41633230739412 mL in 1 VIAL, SINGLE-USE2 mlHistorical