FDA.reportPublic FDA data

Famotidine

Product NDC
0641-6021
11-digit product format
006416021
Labeler code
0641
Product ID
0641-6021_021158a6-1da8-477a-af20-4ce26c147b32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA075488
Marketing category
ANDA
Marketing start
2001-04-16
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, 1743833

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6021-01Famotidine20 mL in 1 VIALINJECTION209
0641-6021-10Famotidine10 in 1 CARTONINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6021-01ML - Milliliter0641-6021613a20d9-c98f-4731-9be1-7db259da908712013-02-13
0641-6021-10ML - Milliliter0641-60216ed8396c-a368-4580-9b5c-58077e01468d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAIFAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AFAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RFAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6021FAMOTIDINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240410_1fdf16e5-145d-4c19-a318-fc6c10794b50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204441famotidine 10 MG/ML Injectable SolutionPSN1fdf16e5-145d-4c19-a318-fc6c10794b509
1743833famotidine 20 MG in 2 ML InjectionPSN1fdf16e5-145d-4c19-a318-fc6c10794b509
17438332 ML famotidine 10 MG/ML InjectionSCD1fdf16e5-145d-4c19-a318-fc6c10794b509
204441famotidine 10 MG/ML Injectable SolutionSCD1fdf16e5-145d-4c19-a318-fc6c10794b509
1743833famotidine 20 MG per 2 ML InjectionSY1fdf16e5-145d-4c19-a318-fc6c10794b509

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6021-010064160210120 mL in 1 VIAL20 mlHistorical
0641-6021-100064160211010 VIAL in 1 CARTON (0641-6021-10) / 20 mL in 1 VIAL (0641-6021-01) 10 vial2001-04-160000-00-00NoNoCurrent