Famotidine

Product NDC
25021-756
11-digit product format
250210756
Labeler code
25021
Product ID
25021-756_82835fd5-d117-4b63-82c2-fe5642fc04dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
NDA219935
Marketing category
NDA
Marketing start
2025-10-15
Marketing end
2027-03-31
Substance
FAMOTIDINE
Active strength
4 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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8

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
25021-756-10Famotidine10 mL in 1 VIALINJECTION, SOLUTION105
25021-756-10Famotidine10 in 1 CARTONINJECTION, SOLUTION105
25021-756-50Famotidine1 in 1 CARTONINJECTION, SOLUTION15
25021-756-50Famotidine50 mL in 1 VIALINJECTION, SOLUTION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-756-10ML - Milliliter25021-75631dbf14b-8feb-4694-bac0-c491f0240a8e12025-12-16
25021-756-50ML - Milliliter25021-7569b33f906-6481-41dc-bd70-aafeaed0b6a512025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2727403famotidine 20 MG in 5 ML InjectionPSN9710995d-b518-40ce-bc2b-8b5dcf002c315
2727402famotidine 4 MG/ML Injectable SolutionPSN9710995d-b518-40ce-bc2b-8b5dcf002c315
27274035 ML famotidine 4 MG/ML InjectionSCD9710995d-b518-40ce-bc2b-8b5dcf002c315
2727402famotidine 4 MG/ML Injectable SolutionSCD9710995d-b518-40ce-bc2b-8b5dcf002c315
2727403famotidine 20 MG per 5 ML InjectionSY9710995d-b518-40ce-bc2b-8b5dcf002c315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-756-102502107561010 VIAL in 1 CARTON (25021-756-10) / 10 mL in 1 VIAL10 vial2025-10-152027-03-31NoNoHistorical
25021-756-50250210756501 VIAL in 1 CARTON (25021-756-50) / 50 mL in 1 VIAL1 vial2025-10-152027-02-28NoNoHistorical