Cinacalcet

Product NDC
50268-153
11-digit product format
502680153
Labeler code
50268
Product ID
50268-153_d8ca1d1f-f97b-480b-e053-2a95a90a096e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA208368
Marketing category
ANDA
Marketing start
2022-02-24
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-153-11EA - Each50268-153dd8c8e44-5322-47f7-9615-e6c1749700c012022-03-09
50268-153-12EA - Each50268-153527e45a4-973c-446d-9e7a-575717cf4dc812022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-153CINACALCET TABLET [AVPAK]2Legacy NDC20240110_d8ca1d1f-f97a-480b-e053-2a95a90a096e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-153-125026801531220 BLISTER PACK in 1 BOX (50268-153-12) > 1 TABLET in 1 BLISTER PACK (50268-153-11) 20 blister pack2022-02-240000-00-00NoNoCurrent