FDA.reportPublic FDA data

Agrylin

Product NDC
54092-063
11-digit product format
540920063
Labeler code
54092
Product ID
54092-063_80829f8c-c5ee-4e37-b5af-1b0e4e4dd5bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
anagrelide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA020333
Marketing category
NDA
Marketing start
1997-03-14
Substance
ANAGRELIDE HYDROCHLORIDE ANHYDROUS
Active strength
.5 mg/1
Pharmacologic classes
Decreased Platelet Production [PE], Phosphodiesterase 3 Inhibitors [MoA], Platelet-reducing Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANAGRELIDE HYDROCHLORIDE ANHYDROUS.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVNS4435G39
Rxcui597850, 597857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbf0d6a5-c6ad-3f7b-f741-62b12bda3a04Product name420220506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54092-063-012021-07-23C16284748780-1c7ccaba7-2406-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use AGRYLIN safely and effectively. See full prescribing information for AGRYLIN. AGRYLIN ® (anagrelide) capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-063-01Agrylin100 in 1 BOTTLECAPSULE10043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-063-01EA - Each54092-0633e6575c7-e6f5-45d7-86ee-c3742e01b36a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANAGRELIDE HYDROCHLORIDEACTIVE INGREDIENTVNS4435G39AGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [SHIRE US MANUFACTURING INC.]24
ANAGRELIDEACTIVE MOIETYK9X45X0051AGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [SHIRE US MANUFACTURING INC.]24
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [SHIRE US MANUFACTURING INC.]24
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [SHIRE US MANUFACTURING INC.]24
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [SHIRE US MANUFACTURING INC.]24
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [SHIRE US MANUFACTURING INC.]24
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [SHIRE US MANUFACTURING INC.]24
POVIDONESINACTIVE INGREDIENTFZ989GH94EAGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [SHIRE US MANUFACTURING INC.]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-063AGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]42Current NDC, Legacy NDC, 1 package rows20250305_cb960074-99c1-4a73-941f-f0644a7ec219.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597857Agrylin 0.5 MG Oral CapsulePSNcb960074-99c1-4a73-941f-f0644a7ec21943
597850anagrelide HCl 0.5 MG Oral CapsulePSNcb960074-99c1-4a73-941f-f0644a7ec21943
597857anagrelide 0.5 MG Oral Capsule [Agrylin]SBDcb960074-99c1-4a73-941f-f0644a7ec21943
597850anagrelide 0.5 MG Oral CapsuleSCDcb960074-99c1-4a73-941f-f0644a7ec21943
597857Agrylin 0.5 MG Oral CapsuleSYcb960074-99c1-4a73-941f-f0644a7ec21943
597850anagrelide 0.5 MG (as anagrelide HCl) Oral CapsuleSYcb960074-99c1-4a73-941f-f0644a7ec21943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54092-063-0154092006301100 CAPSULE in 1 BOTTLE (54092-063-01) 100 capsule1997-03-140000-00-00NoNoCurrent