Home NDC 42291-461 Cinacalcet
Product NDC 42291-461
11-digit product format 422910461
Labeler code 42291
Product ID 42291-461_ec19dc56-fb39-4ed8-e053-2995a90a1923
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cinacalcet
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA206125
Marketing category ANDA
Marketing start 2021-07-27
Marketing end 0000-00-00
Substance CINACALCET HYDROCHLORIDE
Active strength 90 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42291-461-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42291-461-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42291-461-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42291-461-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42291-461-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42291-461-30 cdf11ea48f46…ba0047e9e063…
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 A206125-001 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 A206125-002 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 A206125-003 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08
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 4 · 123 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 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206125-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2018-03-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206125-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2018-03-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206125-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2018-03-08 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 Marketing start Marketing end Sample Exclude flag Status 42291-461-30 42291046130 30 TABLET, FILM COATED in 1 BOTTLE (42291-461-30) 2021-07-27 0000-00-00 No No Current