Home NDC 43598-368 Cinacalcet
Product NDC 43598-368
11-digit product format 435980368
Labeler code 43598
Product ID 43598-368_b6dbd55a-a71d-0cf8-2c73-7ebbfc032906
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cinacalcet
Dosage form TABLET
Route ORAL
Labeler Dr. Reddys Laboratories Inc
Application ANDA208368
Marketing category ANDA
Marketing start 2020-09-18
Marketing end 2026-11-30
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
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Cinacalcet 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 43598-368-05 Cinacalcet 500 in 1 BOTTLE TABLET 500 11 43598-368-30 Cinacalcet 30 in 1 BOTTLE TABLET 30 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-368 CINACALCET TABLET [DR. REDDYS LABORATORIES INC] 11 Current NDC, Legacy NDC, 2 package rows 20240413_0837aabc-e796-0e07-8958-71f1ff6e89bf.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 Units Marketing start Marketing end Sample Exclude flag Status 43598-368-05 43598036805 500 TABLET in 1 BOTTLE (43598-368-05) 500 tablet 2020-09-18 2026-11-30 No No Current 43598-368-30 43598036830 30 TABLET in 1 BOTTLE (43598-368-30) 30 tablet 2020-09-18 2026-11-30 No No Current