Cinacalcet

Product NDC
67877-505
11-digit product format
678770505
Labeler code
67877
Product ID
67877-505_7dc83b54-a624-48db-ad2d-ee000a6d9c47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cinacalcet
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210570
Marketing category
ANDA
Marketing start
2019-05-18
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210570-001CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-17
A210570-002CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-17
A210570-003CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210570-001AB
A210570-002AB
A210570-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210570-002CINACALCET HYDROCHLORIDEEQ 60MG BASETABLET / ORALAB2019-05-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210570-003CINACALCET HYDROCHLORIDEEQ 90MG BASETABLET / ORALAB2019-05-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210570-001CINACALCET HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2019-05-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210570-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210570-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210570-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210570-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210570-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210570-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210570-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210570-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210570-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210570-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210570-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210570-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210570-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210570-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210570-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210570-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210570-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210570-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210570-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210570-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210570-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210570-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210570-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210570-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210570-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210570-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210570-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210570-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210570-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210570-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210570-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210570-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210570-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210570-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210570-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210570-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210570-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210570-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210570-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210570-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Cinacalcet
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINACALCET HYDROCHLORIDE90 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K860WSG25Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
432400Internal RxNorm lookup
432401Internal RxNorm lookup
432402Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55f95ae0-84ac-4ae4-b7a0-7590ab919ae1Available on FDA.report

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
67877-505-01Cinacalcet100 in 1 BOTTLETABLET, FILM COATED10011
67877-505-30Cinacalcet30 in 1 BOTTLETABLET, FILM COATED3011
67877-505-33Cinacalcet10 in 1 CARTONTABLET, FILM COATED1011
67877-505-33Cinacalcet10 in 1 BLISTER PACKTABLET, FILM COATED1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-505-30EA - Each67877-505816158f6-8777-4fc1-a912-2bb187404c7012019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-505CINACALCET TABLET, FILM COATED [ASCEND LABORATORIES, LLC]10Current NDC, Legacy NDC, 4 package rows20220722_55f95ae0-84ac-4ae4-b7a0-7590ab919ae1.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CinacalcetCINACALCETBryant Ranch Prepack79b64bbb-3682-4b31-9bb6-03e2c5ac5a2c2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
CinacalcetCINACALCETBryant Ranch Prepack330b4214-dba7-468c-a67e-b1057f4628da2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
CinacalcetCINACALCETBryant Ranch Prepackf1cfc943-5b70-4451-a1fc-61e45e669d842026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
CinacalcetCINACALCETBryant Ranch Prepack60e6264c-723c-49b2-a246-827b15ff219c2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
CinacalcetCINACALCETBryant Ranch Prepackb920a91f-309f-4f83-a123-525b3bdd55b72026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
CinacalcetCINACALCETBryant Ranch Prepacke96cfada-3763-4af7-b323-1256926a797c2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
CinacalcetCINACALCETBryant Ranch Prepack86fe67f9-d4e0-4966-a80b-c04bf6bb0ef92026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
CinacalcetCINACALCETBryant Ranch Prepackc288922b-3258-4c1c-bd8a-32a41dd43a632026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
CinacalcetCINACALCETAscend Laboratories, LLC55f95ae0-84ac-4ae4-b7a0-7590ab919ae12026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210570
application number: ANDA210570
ndc (product): 67877-505

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
432400cinacalcet HCl 90 MG Oral TabletPSNb71d56b8-9c03-4347-8752-8a04825a1add105
432400cinacalcet 90 MG Oral TabletSCDb71d56b8-9c03-4347-8752-8a04825a1add105
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSYb71d56b8-9c03-4347-8752-8a04825a1add105
432400cinacalcet HCl 90 MG Oral TabletPSNb920a91f-309f-4f83-a123-525b3bdd55b7102
432400cinacalcet 90 MG Oral TabletSCDb920a91f-309f-4f83-a123-525b3bdd55b7102
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSYb920a91f-309f-4f83-a123-525b3bdd55b7102
432400cinacalcet HCl 90 MG Oral TabletPSNf1cfc943-5b70-4451-a1fc-61e45e669d84100
432400cinacalcet 90 MG Oral TabletSCDf1cfc943-5b70-4451-a1fc-61e45e669d84100
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSYf1cfc943-5b70-4451-a1fc-61e45e669d84100
432402cinacalcet HCl 30 MG Oral TabletPSN55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432401cinacalcet HCl 60 MG Oral TabletPSN55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432400cinacalcet HCl 90 MG Oral TabletPSN55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432402cinacalcet 30 MG Oral TabletSCD55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432401cinacalcet 60 MG Oral TabletSCD55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432400cinacalcet 90 MG Oral TabletSCD55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432402cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral TabletSY55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432401cinacalcet 60 MG (as cinacalcet HCl 66 MG) Oral TabletSY55f95ae0-84ac-4ae4-b7a0-7590ab919ae111
432400cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral TabletSY55f95ae0-84ac-4ae4-b7a0-7590ab919ae111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-505-0167877050501100 TABLET, FILM COATED in 1 BOTTLE (67877-505-01) 2019-05-180000-00-00NoNoCurrent
67877-505-306787705053030 TABLET, FILM COATED in 1 BOTTLE (67877-505-30) 2019-05-180000-00-00NoNoCurrent
67877-505-336787705053310 BLISTER PACK in 1 CARTON (67877-505-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2019-05-180000-00-00NoNoCurrent