Famotidine

Product NDC
40032-500
11-digit product format
400320500
Labeler code
40032
Product ID
40032-500_d476f4fa-86f9-45f0-bfb0-64b3e34a6d83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA201695
Marketing category
ANDA
Marketing start
2012-12-17
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-500-112020-01-31C16284748780-19d75b9d0-9442-f424-e053-dadaa90a57ceFamotidine for Oral Suspension, USP Novel Laboratories, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-500-11Famotidine50 mL in 1 BOTTLEFOR SUSPENSION504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKFAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-500FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.]4Legacy NDC, 1 package rows20130108_a6330a0d-4c67-4019-9700-7383fad7cbc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310274famotidine 40 MG in 5 mL Oral SuspensionPSNa6330a0d-4c67-4019-9700-7383fad7cbc74
310274famotidine 8 MG/ML Oral SuspensionSCDa6330a0d-4c67-4019-9700-7383fad7cbc74
310274famotidine 40 MG per 5 ML Oral SuspensionSYa6330a0d-4c67-4019-9700-7383fad7cbc74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
40032-500-114003205001150 mL in 1 BOTTLE50 mlHistorical