FDA.reportPublic FDA data

Famotidine

Product NDC
68180-150
11-digit product format
681800150
Labeler code
68180
Product ID
68180-150_ce0e39ea-0d29-4922-95cb-8777326a994e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090440
Marketing category
ANDA
Marketing start
2010-06-29
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
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
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-150-01Famotidine50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-150-01ML - Milliliter68180-15062fd80b9-f8a9-4b7a-a518-7b67a38680e112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKFAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MFAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NFAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4
SUCROSEINACTIVE INGREDIENTC151H8M554FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-150FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20200425_2caaf94b-b382-4573-8614-57815776b659.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310274famotidine 40 MG in 5 mL Oral SuspensionPSN2caaf94b-b382-4573-8614-57815776b6599
310274famotidine 8 MG/ML Oral SuspensionSCD2caaf94b-b382-4573-8614-57815776b6599
310274famotidine 40 MG per 5 ML Oral SuspensionSY2caaf94b-b382-4573-8614-57815776b6599

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-150-016818001500150 mL in 1 BOTTLE (68180-150-01) 50 ml2010-06-290000-00-00NoNoCurrent