Cinacalcet

Product NDC
43598-369
11-digit product format
435980369
Labeler code
43598
Product ID
43598-369_e07f5026-c912-d0cd-0457-1649176c8b70
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
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43598-369DDiscontinued by firm2026-08-11
excluded packagepackage43598-36943598-369-05DDiscontinued by firm2026-08-11
excluded packagepackage43598-36943598-369-30DDiscontinued by firm2026-08-11

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208368-001CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-18
A208368-002CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-18
A208368-003CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208368-001AB
A208368-002AB
A208368-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208368-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2020-09-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208368-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2020-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208368-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2020-09-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208368-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208368-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208368-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208368-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208368-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208368-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208368-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208368-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208368-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208368-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208368-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208368-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208368-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208368-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208368-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208368-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208368-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208368-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208368-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208368-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208368-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208368-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208368-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208368-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208368-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208368-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208368-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208368-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208368-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208368-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208368-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208368-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208368-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208368-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208368-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208368-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208368-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208368-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208368-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208368-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d7bb05-5b36-6931-a2f8-2f1eeddcdb03Product name320181011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-369-05Cinacalcet500 in 1 BOTTLETABLET50011
43598-369-30Cinacalcet30 in 1 BOTTLETABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-369CINACALCET TABLET [DR. REDDYS LABORATORIES INC]11Legacy NDC, 2 package rows20240413_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CinacalcetCINACALCETDr. Reddys Laboratories Inc0837aabc-e796-0e07-8958-71f1ff6e89bf2024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208368
application number: ANDA208368
ndc (product): 43598-369

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432402cinacalcet HCl 30 MG Oral TabletPSN0837aabc-e796-0e07-8958-71f1ff6e89bf11
432401cinacalcet HCl 60 MG Oral TabletPSN0837aabc-e796-0e07-8958-71f1ff6e89bf11
432400cinacalcet HCl 90 MG Oral TabletPSN0837aabc-e796-0e07-8958-71f1ff6e89bf11
432402cinacalcet 30 MG Oral TabletSCD0837aabc-e796-0e07-8958-71f1ff6e89bf11
432401cinacalcet 60 MG Oral TabletSCD0837aabc-e796-0e07-8958-71f1ff6e89bf11
432400cinacalcet 90 MG Oral TabletSCD0837aabc-e796-0e07-8958-71f1ff6e89bf11
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY0837aabc-e796-0e07-8958-71f1ff6e89bf11
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY0837aabc-e796-0e07-8958-71f1ff6e89bf11
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY0837aabc-e796-0e07-8958-71f1ff6e89bf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-369-0543598036905500 TABLET in 1 BOTTLE (43598-369-05) 500 tablet2020-09-180000-00-00NoNoCurrent
43598-369-304359803693030 TABLET in 1 BOTTLE (43598-369-30) 30 tablet2020-09-180000-00-00NoNoCurrent