Home NDC 68180-228-06 Cinacalcet
Product NDC 68180-228
Requested package NDC 68180-228-06
11-digit product format 681800228
Labeler code 68180
Product ID 68180-228_b1817292-e161-41bf-8d75-34ad16a49648
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cinacalcet
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA210548
Marketing category ANDA
Marketing start 2020-06-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A210548-001 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 A210548-002 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 A210548-003 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28
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 · 129 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 2026-09-14 22:38:34 2026-08 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210548-002 CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET / ORAL 2019-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210548-003 CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL 2019-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210548-001 CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2019-06-28 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68180-228-06 68180022806 30 TABLET, FILM COATED in 1 BOTTLE (68180-228-06) 2020-06-01 0000-00-00 No No Current