Home NDC 84386-113 Cinacalcet
Product NDC 84386-113
11-digit product format 843860113
Labeler code 84386
Product ID 84386-113_200390f2-7dad-4ecc-a086-c29e18525c01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cinacalcet
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA206125
Marketing category ANDA
Marketing start 2026-03-23
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 2027-12-31
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Cinacalcet
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CINACALCET HYDROCHLORIDE 90 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 84386-113-01 Cinacalcet 100 in 1 BOTTLE TABLET, FILM COATED 100 1 84386-113-05 Cinacalcet 500 in 1 BOTTLE TABLET, FILM COATED 500 1 84386-113-30 Cinacalcet 30 in 1 BOTTLE TABLET, FILM COATED 30 1 84386-113-90 Cinacalcet 90 in 1 BOTTLE TABLET, FILM COATED 90 1
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 Sample Exclude flag Status 84386-113-01 84386011301 100 TABLET, FILM COATED in 1 BOTTLE (84386-113-01) 2026-03-23 No No Current 84386-113-05 84386011305 500 TABLET, FILM COATED in 1 BOTTLE (84386-113-05) 2026-03-23 No No Current 84386-113-30 84386011330 30 TABLET, FILM COATED in 1 BOTTLE (84386-113-30) 2026-03-23 No No Current 84386-113-90 84386011390 90 TABLET, FILM COATED in 1 BOTTLE (84386-113-90) 2026-03-23 No No Current