METOLAZONE

Product NDC
76519-1166
11-digit product format
765191166
Labeler code
76519
Product ID
76519-1166_6856a354-e850-10cc-e053-2a91aa0a5e70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOLAZONE
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Co., Inc.
Application
NDA017386
Marketing category
NDA
Marketing start
2017-12-08
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
76519-1166-02020-01-31C16284748780-19d75b9d0-695b-f424-e053-dadaa90a57ce6856a354-e84f-10cc-e053-2a91aa0a5e70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1166-0METOLAZONE100 in 1 VIALTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1166METOLAZONE TABLET [H.J. HARKINS CO., INC.]1Legacy NDC, 1 package rows20180328_6856a354-e84f-10cc-e053-2a91aa0a5e70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311671metOLazone 5 MG Oral TabletPSN6856a354-e84f-10cc-e053-2a91aa0a5e701
311671metolazone 5 MG Oral TabletSCD6856a354-e84f-10cc-e053-2a91aa0a5e701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1166-076519116600100 in 1 VIALHistorical