Home NDC 16729-441 CINACALCET
Product NDC 16729-441
11-digit product format 167290441
Labeler code 16729
Product ID 16729-441_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 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A211892-001 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 A211892-002 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 A211892-003 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15
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 · 114 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 2026-08-18 06:07:40 2026-07 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211892-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL AB 2020-05-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211892-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL AB 2020-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211892-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2020-05-15 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CINACALCET
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CINACALCET HYDROCHLORIDE 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K860WSG25 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 432400 Internal RxNorm lookup 432401 Internal RxNorm lookup 432402 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16729-441-01 CINACALCET 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 8 16729-441-10 CINACALCET 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 8 16729-441-15 CINACALCET 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-441 CINACALCET TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20240712_6bad4e06-c0a1-4123-83c2-67d3b081e8a9.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16729-441-01 16729044101 100 in 1 BOTTLE, PLASTIC Historical 16729-441-10 16729044110 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-10) 2020-06-16 0000-00-00 No No Current 16729-441-15 16729044115 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-15) 2020-06-19 0000-00-00 No No Current