FDA.reportPublic FDA data

CINACALCET

Product NDC
69097-411
11-digit product format
690970411
Labeler code
69097
Product ID
69097-411_383a7dc8-b195-4868-8774-f16a5558771e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CINACALCET
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA208915
Marketing category
ANDA
Marketing start
2018-03-08
Substance
CINACALCET HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K860WSG25
Rxcui432400, 432401, 432402

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03Product name320181011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-411-02CINACALCET30 in 1 BOTTLETABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-411-02EA - Each69097-411d6cef823-d87e-4de6-bb60-d3ffcc631e4b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-411CINACALCET TABLET [CIPLA USA INC.]12Current NDC, Legacy NDC, 1 package rows20240515_02b8c11b-99e8-4039-b6fa-a9c38d2f48fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432401cinacalcet HCl 60 MG Oral TabletPSN93e94a24-fe2f-4ce6-bd1b-0d51be4e74bc100
432401cinacalcet 60 MG Oral TabletSCD93e94a24-fe2f-4ce6-bd1b-0d51be4e74bc100
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY93e94a24-fe2f-4ce6-bd1b-0d51be4e74bc100
432402cinacalcet HCl 30 MG Oral TabletPSN02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13
432401cinacalcet HCl 60 MG Oral TabletPSN02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13
432400cinacalcet HCl 90 MG Oral TabletPSN02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13
432402cinacalcet 30 MG Oral TabletSCD02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13
432401cinacalcet 60 MG Oral TabletSCD02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13
432400cinacalcet 90 MG Oral TabletSCD02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY02b8c11b-99e8-4039-b6fa-a9c38d2f48fa13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-411-026909704110230 TABLET in 1 BOTTLE (69097-411-02) 30 tablet2018-03-080000-00-00NoNoCurrent