FDA.reportPublic FDA data

Cinacalcet

Product NDC
60687-516
11-digit product format
606870516
Labeler code
60687
Product ID
60687-516_2e20c61e-13d1-5160-e063-6294a90a4d36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209226
Marketing category
ANDA
Marketing start
2025-05-18
Substance
CINACALCET HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432402

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03Product name320181011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-516-11Cinacalcet1 in 1 BLISTER PACKTABLET, FILM COATED11
60687-516-21Cinacalcet30 in 1 CARTONTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-516-11EA - Each60687-516a3bc16af-4e8b-481a-88a8-dd35f853811d12025-06-13
60687-516-21EA - Each60687-51691c331a6-e293-47c9-bbb3-fdcf91dadb4612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-516CINACALCET TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20250523_44b548ef-1679-4d15-86ad-0d9636b48a45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN44b548ef-1679-4d15-86ad-0d9636b48a451
432402cinacalcet 30 MG Oral TabletSCD44b548ef-1679-4d15-86ad-0d9636b48a451
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY44b548ef-1679-4d15-86ad-0d9636b48a451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-516-11606870516111 in 1 BLISTER PACKHistorical
60687-516-216068705162130 BLISTER PACK in 1 CARTON (60687-516-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-516-11) 30 blister pack2025-05-18NoNoHistorical