FDA.reportPublic FDA data

CINACALCET

Product NDC
16729-440
11-digit product format
167290440
Labeler code
16729
Product ID
16729-440_40aa0834-3fd8-c230-e063-6294a90a800d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA211892
Marketing category
ANDA
Marketing start
2020-06-16
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
Rxcui432400, 432401, 432402

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
16729-440-01CINACALCET100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1008
16729-440-10CINACALCET30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308
16729-440-15CINACALCET90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-440-10EA - Each16729-44019c2874c-a057-4336-a423-5664c3dc443212020-06-05
16729-440-15EA - Each16729-44033096cb0-04cd-4573-9670-65a1591ca7d612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-440CINACALCET TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]7Current NDC, Legacy NDC, 3 package rows20240712_6bad4e06-c0a1-4123-83c2-67d3b081e8a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN6bad4e06-c0a1-4123-83c2-67d3b081e8a98
432401cinacalcet HCl 60 MG Oral TabletPSN6bad4e06-c0a1-4123-83c2-67d3b081e8a98
432400cinacalcet HCl 90 MG Oral TabletPSN6bad4e06-c0a1-4123-83c2-67d3b081e8a98
432402cinacalcet 30 MG Oral TabletSCD6bad4e06-c0a1-4123-83c2-67d3b081e8a98
432401cinacalcet 60 MG Oral TabletSCD6bad4e06-c0a1-4123-83c2-67d3b081e8a98
432400cinacalcet 90 MG Oral TabletSCD6bad4e06-c0a1-4123-83c2-67d3b081e8a98
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY6bad4e06-c0a1-4123-83c2-67d3b081e8a98
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY6bad4e06-c0a1-4123-83c2-67d3b081e8a98
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY6bad4e06-c0a1-4123-83c2-67d3b081e8a98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-440-0116729044001100 in 1 BOTTLE, PLASTICHistorical
16729-440-101672904401030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-440-10) 2020-06-160000-00-00NoNoCurrent
16729-440-151672904401590 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-440-15) 2020-06-190000-00-00NoNoCurrent