Famotidine

Product NDC
25021-753
11-digit product format
250210753
Labeler code
25021
Product ID
25021-753_11856fb6-3d0b-4db4-889f-083e7f4285be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA075622
Marketing category
ANDA
Marketing start
2024-12-15
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
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
25021-753-02Famotidine2 mL in 1 VIALINJECTION, SOLUTION21
25021-753-02Famotidine25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-753-02ML - Milliliter25021-7534acfd9ed-45b6-4efa-9451-2a1f17d252de12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-753FAMOTIDINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20241215_2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c958.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204441famotidine 10 MG/ML Injectable SolutionPSN2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c9581
1743833famotidine 20 MG in 2 ML InjectionPSN2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c9581
1743833famotidine 20 MG in 2 ML InjectionPSN4e803491-8030-50d0-e063-6294a90a5c8d1
17438332 ML famotidine 10 MG/ML InjectionSCD2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c9581
17438332 ML famotidine 10 MG/ML InjectionSCD4e803491-8030-50d0-e063-6294a90a5c8d1
204441famotidine 10 MG/ML Injectable SolutionSCD2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c9581
1743833famotidine 20 MG per 2 ML InjectionSY2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c9581
1743833famotidine 20 MG per 2 ML InjectionSY4e803491-8030-50d0-e063-6294a90a5c8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-753-022502107530225 VIAL in 1 CARTON (25021-753-02) / 2 mL in 1 VIAL25 vial2024-12-15NoNoHistorical