metolazone

Product NDC
65580-644
11-digit product format
655800644
Labeler code
65580
Product ID
65580-644_5716d764-3691-4ebc-8e42-dbcac00f48a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metolazone
Dosage form
TABLET
Route
ORAL
Labeler
Upstate Pharma, LLC
Application
NDA017386
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1973-11-27
Marketing end
0000-00-00
Substance
METOLAZONE
Active strength
5 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide-like Diuretic [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
4e48c581-6027-290d-65f0-1b09c39dc1e8Product name620250625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65580-644-712020-01-31C16284748780-19d75b9cf-eefd-f424-e053-dadaa90a57ceMetolazone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65580-644-71metolazone100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65580-644-71EA - Each65580-64444fe9a14-3051-4ea4-8f4c-c77cee4c207312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metolazoneACTIVE INGREDIENTTZ7V40X7VXMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
metolazoneACTIVE MOIETYTZ7V40X7VXMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKMETOLAZONE TABLET [UPSTATE PHARMA, LLC]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8METOLAZONE TABLET [UPSTATE PHARMA, LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30METOLAZONE TABLET [UPSTATE PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65580-644METOLAZONE TABLET [UPSTATE PHARMA, LLC]3Legacy NDC, 1 package rows20150611_f45f5353-38a3-42c6-bffc-96bea8dcf818.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197978metOLazone 10 MG Oral TabletPSNf45f5353-38a3-42c6-bffc-96bea8dcf8183
197979metOLazone 2.5 MG Oral TabletPSNf45f5353-38a3-42c6-bffc-96bea8dcf8183
311671metOLazone 5 MG Oral TabletPSNf45f5353-38a3-42c6-bffc-96bea8dcf8183
197978metolazone 10 MG Oral TabletSCDf45f5353-38a3-42c6-bffc-96bea8dcf8183
197979metolazone 2.5 MG Oral TabletSCDf45f5353-38a3-42c6-bffc-96bea8dcf8183
311671metolazone 5 MG Oral TabletSCDf45f5353-38a3-42c6-bffc-96bea8dcf8183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65580-644-7165580064471100 in 1 BOTTLE, PLASTICHistorical