FDA.reportPublic FDA data

FAMOTIDINE

Product NDC
59651-701
11-digit product format
596510701
Labeler code
59651
Product ID
59651-701_186342b3-2a01-4582-8978-41f059d4307d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219091
Marketing category
ANDA
Marketing start
2025-07-09
Substance
FAMOTIDINE
Active strength
40 mg/5mL
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
FAMOTIDINE40 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310274

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-701-50FAMOTIDINE50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-701-50ML - Milliliter59651-7010096942c-4fec-48de-949e-f9e78f19b92812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310274famotidine 40 MG in 5 mL Oral SuspensionPSN18066b80-1ec6-4092-80d9-70adb0ecac852
310274famotidine 8 MG/ML Oral SuspensionSCD18066b80-1ec6-4092-80d9-70adb0ecac852
310274famotidine 40 MG per 5 ML Oral SuspensionSY18066b80-1ec6-4092-80d9-70adb0ecac852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-701-505965107015050 mL in 1 BOTTLE (59651-701-50) 50 ml2025-07-09NoNoHistorical