metyrosine

Product NDC
69238-1621
11-digit product format
692381621
Labeler code
69238
Product ID
69238-1621_30339825-d8d3-4000-ad4d-edbbd76c4e25
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
Substance
METYROSINE
Active strength
250 mg/1
Pharmacologic classes
Catecholamine Synthesis Inhibitor [EPC], Catecholamine Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
metyrosine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METYROSINE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDOQ0J0TPF7
Rxcui197980

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c854e70c-e05b-1969-e1ff-89d3d09d1b16Product name420260122
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1621-1metyrosine100 in 1 BOTTLE, PLASTICCAPSULE1007
69238-1621-3metyrosine30 in 1 BOTTLE, PLASTICCAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1621-3EA - Each69238-1621d94d9cb1-1929-493d-afd1-b7a61a93211d12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1621METYROSINE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, Legacy NDC, 2 package rows20230112_027f02b1-be49-4822-91a5-6cd66b56c0e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197980metyroSINE 250 MG Oral CapsulePSN027f02b1-be49-4822-91a5-6cd66b56c0e17
197980metyrosine 250 MG Oral CapsuleSCD027f02b1-be49-4822-91a5-6cd66b56c0e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1621-169238162101100 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-1) 100 capsule2020-07-240000-00-00NoNoCurrent
69238-1621-36923816210330 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-3) 30 capsule2020-12-150000-00-00NoNoCurrent