Home NDC 76075-102 KYPROLIS
Product NDC 76075-102
11-digit product format 760750102
Labeler code 76075
Product ID 76075-102_600cd22c-3a74-442e-a65d-c06d47bb892a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carfilzomib
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Onyx Pharmaceuticals, Inc.
Application NDA202714
Marketing category NDA
Marketing start 2016-07-15
Substance CARFILZOMIB
Active strength 30 mg/15mL
Pharmacologic classes Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 N202714-001 KYPROLIS CARFILZOMIB 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 N202714-002 KYPROLIS CARFILZOMIB 30MG/VIAL POWDER / INTRAVENOUS RLD, RS 2016-06-03 N202714-003 KYPROLIS CARFILZOMIB 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-06-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202714-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 30 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202714-001 7417042 2026-07-20 Drug substance, Drug product 2012-08-09 N202714-001 7417042*PED 2027-01-20 Pediatric extension N202714-001 7737112 2027-12-07 Drug product 2012-08-09 N202714-001 7737112*PED 2028-06-07 Pediatric extension N202714-001 RE47954 2029-10-21 U-3449 2022-10-18 N202714-001 RE47954*PED 2030-04-21 Pediatric extension N202714-001 9493582 2033-02-27 Drug product 2017-03-09 N202714-001 9493582*PED 2033-08-27 Pediatric extension N202714-001 12636340 2041-04-29 U-4551 2026-06-23 N202714-001 12636340*PED 2041-10-29 Pediatric extension N202714-002 7417042 2026-07-20 Drug substance, Drug product 2016-08-15 N202714-002 7417042*PED 2027-01-20 Pediatric extension N202714-002 7737112 2027-12-07 Drug product 2016-08-15 N202714-002 7737112*PED 2028-06-07 Pediatric extension N202714-002 RE47954 2029-10-21 U-3449 2022-10-18 N202714-002 RE47954*PED 2030-04-21 Pediatric extension N202714-002 9493582 2033-02-27 Drug product 2017-03-09 N202714-002 9493582*PED 2033-08-27 Pediatric extension N202714-002 12636340 2041-04-29 U-4551 2026-06-23 N202714-002 12636340*PED 2041-10-29 Pediatric extension N202714-003 7417042 2026-07-20 Drug substance, Drug product 2018-06-20 N202714-003 7417042*PED 2027-01-20 Pediatric extension N202714-003 7737112 2027-12-07 Drug product 2018-06-20 N202714-003 7737112*PED 2028-06-07 Pediatric extension N202714-003 RE47954 2029-10-21 U-3449 2022-10-18 N202714-003 RE47954*PED 2030-04-21 Pediatric extension N202714-003 9493582 2033-02-27 Drug product 2018-06-20 N202714-003 9493582*PED 2033-08-27 Pediatric extension N202714-003 12636340 2041-04-29 U-4551 2026-06-23 N202714-003 12636340*PED 2041-10-29 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 · 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 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD, RS 2016-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-06-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD, RS 2016-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-06-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD, RS 2016-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD, RS 2016-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD, RS 2016-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2018-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD 2016-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD 2018-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD 2016-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD 2018-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD 2016-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD 2018-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD 2016-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD 2018-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD 2016-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD 2018-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD 2016-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD 2018-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD 2016-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD 2018-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202714-002 KYPROLIS 30MG/VIAL POWDER / INTRAVENOUS RLD 2016-06-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202714-003 KYPROLIS 10MG/VIAL POWDER / INTRAVENOUS RLD 2018-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202714-001 KYPROLIS 60MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2012-07-20 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 57 · 2,277 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N202714-001 7417042 2026-07-20 Drug substance, Drug product 2012-08-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 7417042*PED 2027-01-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 7737112 2027-12-07 Drug product 2012-08-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 7737112*PED 2028-06-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 RE47954 2029-10-21 U-3449 2022-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 RE47954*PED 2030-04-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 9493582 2033-02-27 Drug product 2017-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 9493582*PED 2033-08-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 12636340 2041-04-29 U-4551 2026-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-001 12636340*PED 2041-10-29 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 7417042 2026-07-20 Drug substance, Drug product 2016-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 7417042*PED 2027-01-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 7737112 2027-12-07 Drug product 2016-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 7737112*PED 2028-06-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 RE47954 2029-10-21 U-3449 2022-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 RE47954*PED 2030-04-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 9493582 2033-02-27 Drug product 2017-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 9493582*PED 2033-08-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 12636340 2041-04-29 U-4551 2026-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-002 12636340*PED 2041-10-29 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 7417042 2026-07-20 Drug substance, Drug product 2018-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 7417042*PED 2027-01-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 7737112 2027-12-07 Drug product 2018-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 7737112*PED 2028-06-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 RE47954 2029-10-21 U-3449 2022-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 RE47954*PED 2030-04-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 9493582 2033-02-27 Drug product 2018-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 9493582*PED 2033-08-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 12636340 2041-04-29 U-4551 2026-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202714-003 12636340*PED 2041-10-29 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202714-001 7417042 2026-07-20 Drug substance, Drug product 2012-08-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 7417042*PED 2027-01-20 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 7737112 2027-12-07 Drug product 2012-08-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 7737112*PED 2028-06-07 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 RE47954 2029-10-21 U-3449 2022-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 RE47954*PED 2030-04-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 9493582 2033-02-27 Drug product 2017-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 9493582*PED 2033-08-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 12636340 2041-04-29 U-4551 2026-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202714-001 12636340*PED 2041-10-29 Pediatric extension caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 147 observed states.
Additional Listing Data#
Finished product Yes
Brand name base KYPROLIS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARFILZOMIB 30 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 72X6E3J5AR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1806934 Internal RxNorm lookup 1806937 Internal RxNorm lookup 1806940 Internal RxNorm lookup 1806942 Internal RxNorm lookup 2046642 Internal RxNorm lookup 2046644 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 76075-102-01 KYPROLIS 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 59 76075-102-01 KYPROLIS 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 15 59 76075-102-21 KYPROLIS 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 15 59 76075-102-21 KYPROLIS 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 59
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARFILZOMIB ACTIVE INGREDIENT 72X6E3J5AR KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] 8 CARFILZOMIB ACTIVE MOIETY 72X6E3J5AR KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] 8 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] 8 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] 8 SULFOBUTYLETHER .BETA.-CYCLODEXTRIN INACTIVE INGREDIENT 2PP9364507 KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] 8 WATER INACTIVE INGREDIENT 059QF0KO0R KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76075-102 KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] 55 Current NDC, Legacy NDC, 4 package rows 20240926_ea66eb30-e665-4693-99a1-a9d3b4bbe2d6.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 76075-102-01 76075010201 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-102-01) / 15 mL in 1 VIAL, SINGLE-DOSE 2016-07-15 0000-00-00 No No Current 76075-102-21 76075010221 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-102-21) / 15 mL in 1 VIAL, SINGLE-DOSE 2025-10-01 No No Current