FDA.reportPublic FDA data

anagrelide

Product NDC
13668-453
11-digit product format
136680453
Labeler code
13668
Product ID
13668-453_a049d02a-22e1-4ea2-8c05-50b50cef4362
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
anagrelide
Dosage form
CAPSULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA209151
Marketing category
ANDA
Marketing start
2017-06-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
anagrelide
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVNS4435G39
Rxcui597850, 597852

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-453-01anagrelide100 in 1 BOTTLECAPSULE10010
13668-453-30anagrelide30 in 1 BOTTLECAPSULE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-453-01EA - Each13668-453384c9b2c-89f7-4009-a46a-e5282c22b2a012018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-453ANAGRELIDE CAPSULE [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, Legacy NDC, 2 package rows20241004_875cc32a-219c-4b6b-802a-98a47cbc9a78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597850anagrelide HCl 0.5 MG Oral CapsulePSN875cc32a-219c-4b6b-802a-98a47cbc9a7810
597852anagrelide HCl 1 MG Oral CapsulePSN875cc32a-219c-4b6b-802a-98a47cbc9a7810
597850anagrelide 0.5 MG Oral CapsuleSCD875cc32a-219c-4b6b-802a-98a47cbc9a7810
597852anagrelide 1 MG Oral CapsuleSCD875cc32a-219c-4b6b-802a-98a47cbc9a7810
597850anagrelide 0.5 MG (as anagrelide HCl) Oral CapsuleSY875cc32a-219c-4b6b-802a-98a47cbc9a7810
597852anagrelide 1 MG (as anagrelide HCl) Oral CapsuleSY875cc32a-219c-4b6b-802a-98a47cbc9a7810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-453-0113668045301100 CAPSULE in 1 BOTTLE (13668-453-01) 100 capsule2017-06-300000-00-00NoNoCurrent
13668-453-301366804533030 CAPSULE in 1 BOTTLE (13668-453-30) 30 capsule2017-06-300000-00-00NoNoCurrent
13668-453-7413668045374100 CAPSULE in 1 CARTON (13668-453-74) 100 capsule2017-06-300000-00-00NoNoCurrent