metyrosine

Product NDC
60219-1621
11-digit product format
602191621
Labeler code
60219
Product ID
60219-1621_d533653d-aa45-4c53-8440-08b2178e64dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metyrosine
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA213734
Marketing category
ANDA
Marketing start
2020-07-24
Marketing end
0000-00-00
Substance
METYROSINE
Active strength
250 mg/1
Pharmacologic classes
Catecholamine Synthesis Inhibitor [EPC],Catecholamine Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c854e70c-e05b-1969-e1ff-89d3d09d1b16Product name420260122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60219-1621-12022-01-28C16284748780-1d6a99b39-fe65-a426-e053-dadaa90af4c2Metyrosine Capsules, USP (250 mg) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1621-1metyrosine100 in 1 BOTTLE, PLASTICCAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1621-1EA - Each60219-1621c5fd349c-daa7-427f-b907-40400044ee3812020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1621METYROSINE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]4Legacy NDC, 1 package rows20201105_ab57037b-11ca-45c5-ac6e-deea64990375.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197980metyroSINE 250 MG Oral CapsulePSNab57037b-11ca-45c5-ac6e-deea649903754
197980metyrosine 250 MG Oral CapsuleSCDab57037b-11ca-45c5-ac6e-deea649903754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-1621-160219162101100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1621-1) 100 capsule2020-07-240000-00-00NoNoCurrent