Famotidine

Product NDC
0338-5197
11-digit product format
003385197
Labeler code
0338
Product ID
0338-5197_bb9e28a8-1076-4c48-9a19-cc43bcd64862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA075591
Marketing category
ANDA
Marketing start
2001-05-10
Substance
FAMOTIDINE
Active strength
20 mg/50mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199739

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
0338-5197-41Famotidine12 in 1 CARTONINJECTION, SOLUTION1220
0338-5197-41Famotidine50 mL in 1 BAGINJECTION, SOLUTION5020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-5197-41ML - Milliliter0338-51972151f01d-2165-4a99-806c-df34e10d270512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-5197FAMOTIDINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]19Current NDC, Legacy NDC, 2 package rows20250507_97c33213-f415-4718-8466-9aa50371af70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199739famotidine 20 MG in 50 ML InjectionPSN97c33213-f415-4718-8466-9aa50371af7020
19973950 ML famotidine 0.4 MG/ML InjectionSCD97c33213-f415-4718-8466-9aa50371af7020
199739famotidine 20 MG per 50 ML InjectionSY97c33213-f415-4718-8466-9aa50371af7020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-5197-410033851974112 BAG in 1 CARTON (0338-5197-41) / 50 mL in 1 BAG12 bag2001-05-100000-00-00NoNoCurrent