Anagrelide

Product NDC
70954-879
11-digit product format
709540879
Labeler code
70954
Product ID
70954-879_56b3959d-4b6b-413f-b753-9d4c20c07466
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anagrelide
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA076811
Marketing category
ANDA
Marketing start
2025-11-06
Substance
ANAGRELIDE HYDROCHLORIDE
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.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYTM763Y5C8
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
70954-879-10Anagrelide100 in 1 BOTTLECAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-879-10EA - Each70954-8798a1733be-7c68-4f0c-9a85-ccc520362f2c12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597850anagrelide HCl 0.5 MG Oral CapsulePSN56b3959d-4b6b-413f-b753-9d4c20c074661
597852anagrelide HCl 1 MG Oral CapsulePSN56b3959d-4b6b-413f-b753-9d4c20c074661
597850anagrelide 0.5 MG Oral CapsuleSCD56b3959d-4b6b-413f-b753-9d4c20c074661
597852anagrelide 1 MG Oral CapsuleSCD56b3959d-4b6b-413f-b753-9d4c20c074661
597850anagrelide 0.5 MG (as anagrelide HCl) Oral CapsuleSY56b3959d-4b6b-413f-b753-9d4c20c074661
597852anagrelide 1 MG (as anagrelide HCl) Oral CapsuleSY56b3959d-4b6b-413f-b753-9d4c20c074661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-879-1070954087910100 CAPSULE in 1 BOTTLE (70954-879-10) 100 capsule2025-11-06NoNoHistorical