Home NDC 55513-075 Sensipar
Product NDC 55513-075
11-digit product format 555130075
Labeler code 55513
Product ID 55513-075_42c2c9c2-6929-4952-b559-a57a1d75424e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cinacalcet hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Amgen Inc
Application NDA021688
Marketing category NDA
Marketing start 2004-04-04
Marketing end 2028-02-28
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
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 N021688-001 SENSIPAR CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL RLD 2004-03-08 N021688-002 SENSIPAR CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL RLD 2004-03-08 N021688-003 SENSIPAR CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL RLD 2004-03-08
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021688-001 7829595 2026-09-22 U-1098 Drug product 2010-12-02 N021688-001 9375405 2026-09-22 Drug product 2016-07-22 N021688-002 7829595 2026-09-22 U-1098 Drug product N021688-002 9375405 2026-09-22 Drug product 2016-07-22 N021688-003 7829595 2026-09-22 U-1098 Drug product N021688-003 9375405 2026-09-22 Drug product 2016-07-22
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 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL RLD 2004-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL RLD 2004-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL RLD 2004-03-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL RLD 2004-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL RLD 2004-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL RLD 2004-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL RLD 2004-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL RLD 2004-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL RLD 2004-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL RLD 2004-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL RLD 2004-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL RLD 2004-03-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL RLD 2004-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL RLD 2004-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL RLD 2004-03-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL RLD 2004-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL RLD 2004-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL RLD 2004-03-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL AB RLD 2004-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL AB RLD 2004-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL AB RLD, RS 2004-03-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL AB RLD 2004-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL AB RLD 2004-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL AB RLD, RS 2004-03-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL AB RLD 2004-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL AB RLD 2004-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL AB RLD, RS 2004-03-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL AB RLD 2004-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL AB RLD 2004-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL AB RLD, RS 2004-03-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL AB RLD 2004-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL AB RLD 2004-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL AB RLD, RS 2004-03-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL AB RLD 2004-03-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL AB RLD 2004-03-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL AB RLD, RS 2004-03-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL AB RLD 2004-03-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021688-002 SENSIPAR EQ 60MG BASE TABLET / ORAL AB RLD 2004-03-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021688-003 SENSIPAR EQ 90MG BASE TABLET / ORAL AB RLD, RS 2004-03-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021688-001 SENSIPAR EQ 30MG BASE TABLET / ORAL AB RLD 2004-03-08 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021688-001 7829595 2026-09-22 U-1098 Drug product 2010-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021688-001 9375405 2026-09-22 Drug product 2016-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021688-002 7829595 2026-09-22 U-1098 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021688-002 9375405 2026-09-22 Drug product 2016-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021688-003 7829595 2026-09-22 U-1098 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021688-003 9375405 2026-09-22 Drug product 2016-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-001 7829595 2026-09-22 U-1098 Drug product 2010-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-001 9375405 2026-09-22 Drug product 2016-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-002 7829595 2026-09-22 U-1098 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-002 9375405 2026-09-22 Drug product 2016-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-003 7829595 2026-09-22 U-1098 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021688-003 9375405 2026-09-22 Drug product 2016-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021688-001 7829595 2026-09-22 U-1098 Drug product 2010-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021688-001 9375405 2026-09-22 Drug product 2016-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021688-002 7829595 2026-09-22 U-1098 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021688-002 9375405 2026-09-22 Drug product 2016-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021688-003 7829595 2026-09-22 U-1098 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021688-003 9375405 2026-09-22 Drug product 2016-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-001 7829595 2026-09-22 U-1098 Drug product 2010-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-001 9375405 2026-09-22 Drug product 2016-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-002 7829595 2026-09-22 U-1098 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-002 9375405 2026-09-22 Drug product 2016-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-003 7829595 2026-09-22 U-1098 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021688-003 9375405 2026-09-22 Drug product 2016-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-001 7829595 2026-09-22 U-1098 Drug product 2010-12-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-001 9375405 2026-09-22 Drug product 2016-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-002 7829595 2026-09-22 U-1098 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-002 9375405 2026-09-22 Drug product 2016-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-003 7829595 2026-09-22 U-1098 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021688-003 9375405 2026-09-22 Drug product 2016-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-001 7829595 2026-09-22 U-1098 Drug product 2010-12-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-001 9375405 2026-09-22 Drug product 2016-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-002 7829595 2026-09-22 U-1098 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-002 9375405 2026-09-22 Drug product 2016-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-003 7829595 2026-09-22 U-1098 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021688-003 9375405 2026-09-22 Drug product 2016-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021688-001 7829595 2026-09-22 U-1098 Drug product 2010-12-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021688-001 9375405 2026-09-22 Drug product 2016-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021688-002 7829595 2026-09-22 U-1098 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021688-002 9375405 2026-09-22 Drug product 2016-07-22 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 45 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sensipar 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 432400 Internal RxNorm lookup 432401 Internal RxNorm lookup 432402 Internal RxNorm lookup 656137 Internal RxNorm lookup 706958 Internal RxNorm lookup 706960 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 55513-075-30 Sensipar 30 in 1 BOTTLE, PLASTIC TABLET, COATED 30 136
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CINACALCET HYDROCHLORIDE ACTIVE INGREDIENT 1K860WSG25 SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124 CINACALCET ACTIVE MOIETY UAZ6V7728S SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124 POVIDONES INACTIVE INGREDIENT FZ989GH94E SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 124
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55513-075 SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC] 135 Current NDC, Legacy NDC, 1 package rows 20241115_45028573-13c4-4c8b-ae62-6c75bba97c81.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 55513-075-30 55513007530 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-075-30) 2004-04-04 2028-02-28 No No Current