FDA.reportPublic FDA data

Anagrelide Hydrochloride

Product NDC
0172-5240
11-digit product format
001725240
Labeler code
0172
Product ID
0172-5240_fc800314-47d7-41ca-af8a-9222fbf5631c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anagrelide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076468
Marketing category
ANDA
Marketing start
2005-04-18
Marketing end
0000-00-00
Substance
ANAGRELIDE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Decreased Platelet Production [PE], Phosphodiesterase 3 Inhibitors [MoA], Platelet-reducing Agent [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0172-5240-60EA - Each0172-5240409beff1-cc15-48bb-b332-43f97b47566b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANAGRELIDE HYDROCHLORIDEACTIVE INGREDIENTVNS4435G39ANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
ANAGRELIDEACTIVE MOIETYK9X45X0051ANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
GELATININACTIVE INGREDIENT2G86QN327LANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
SHELLACINACTIVE INGREDIENT46N107B71OANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANAGRELIDE HYDROCHLORIDE CAPSULE [IVAX PHARMACEUTICALS, INC.]15
Anagrelide HydrochlorideACTIVE INGREDIENTVNS4435G39ANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
AnagrelideACTIVE MOIETYK9X45X0051ANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANAGRELIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0172-5240ANAGRELIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]26Legacy NDC20250529_6727d5d4-e8ec-4a85-bc82-ec70b641eecf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597850anagrelide HCl 0.5 MG Oral CapsulePSN5e6cf1e5-94e4-4124-b7bf-e746475322462
597852anagrelide HCl 1 MG Oral CapsulePSN5e6cf1e5-94e4-4124-b7bf-e746475322462
597850anagrelide 0.5 MG Oral CapsuleSCD5e6cf1e5-94e4-4124-b7bf-e746475322462
597852anagrelide 1 MG Oral CapsuleSCD5e6cf1e5-94e4-4124-b7bf-e746475322462
597850anagrelide 0.5 MG (as anagrelide HCl) Oral CapsuleSY5e6cf1e5-94e4-4124-b7bf-e746475322462
597852anagrelide 1 MG (as anagrelide HCl) Oral CapsuleSY5e6cf1e5-94e4-4124-b7bf-e746475322462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0172-5240-6000172524060100 CAPSULE in 1 BOTTLE (0172-5240-60) 100 capsule2005-04-180000-00-00NoNoCurrent