Home NDC 50268-153-12 Cinacalcet
Product NDC 50268-153
Requested package NDC 50268-153-12
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50268-153 50268-153-12 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50268-153 50268-153-12 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208368-001 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 A208368-002 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 A208368-003 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 111 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208368-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208368-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208368-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-09-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-153 CINACALCET TABLET [AVPAK] 2 Legacy NDC 20240110_d8ca1d1f-f97a-480b-e053-2a95a90a096e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-153-12 50268015312 20 BLISTER PACK in 1 BOX (50268-153-12) > 1 TABLET in 1 BLISTER PACK (50268-153-11) 20 blister pack 2022-02-24 0000-00-00 No No Current