VELCADE

Product NDC: 63020-049
11-digit product format: 630200049
Labeler code: 63020
Product ID: 63020-049_3ec85e73-696a-4a2e-aa24-656c6341b23b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bortezomib
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA021602
Marketing category: NDA
Marketing start: 2003-05-13
Substance: BORTEZOMIB
Active strength: 3.5 mg/1
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021602-001	VELCADE	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021602-001	AP

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 2 · 42 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
2026-08-18 06:07:40	2026-07	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2003-05-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021602-001	VELCADE	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2003-05-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021602-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021602-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021602-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021602-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021602-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021602-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021602-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021602-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021602-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021602-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021602-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021602-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021602-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021602-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021602-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021602-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021602-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021602-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021602-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021602-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021602-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021602-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021602-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021602-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021602-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021602-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021602-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021602-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021602-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021602-001	6713446	2022-01-25	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021602-001	6958319	2022-01-25	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021602-001	6713446*PED	2022-07-25	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021602-001	6958319*PED	2022-07-25	Pediatric extension	`c0c555d07b60…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021602-001	PED	2022-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021602-001	PED	2022-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021602-001	PED	2022-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021602-001	PED	2019-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	ODE-76	2021-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021602-001	PED	2022-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021602-001	PED	2022-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021602-001	ODE-76	2021-10-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021602-001	PED	2022-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	ODE-76	2021-10-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021602-001	PED	2022-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021602-001	ODE-76	2021-10-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021602-001	PED	2022-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021602-001	ODE-76	2021-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021602-001	PED	2022-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021602-001	ODE-76	2021-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021602-001	PED	2022-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021602-001	PED	2019-03-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021602-001	ODE-76	2021-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021602-001	PED	2022-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021602-001	PED	2019-03-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021602-001	ODE-76	2021-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021602-001	PED	2022-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021602-001	PED	2019-03-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021602-001	ODE-76	2021-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021602-001	PED	2022-04-08	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021602-001	PED	2022-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021602-001	PED	2022-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021602-001	PED	2022-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021602-001	PED	2022-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021602-001	PED	2022-04-08	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: VELCADE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BORTEZOMIB	3.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
69G8BD63PP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402243	Internal RxNorm lookup
402244	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1521d321-e724-4ffc-adad-34bf4f44fac7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b069d653-565d-b331-cf82-116aa266aee9	Product name	4	20260317
987023d7-918d-4465-be3c-f3f8f784679b	Product name	1	20250318
2cff6375-aa9a-4194-a1db-33f6ed6564f1	Product name	1	20230322
f8ade071-6be1-4cb3-a390-e8ba41353f9b	Product name	1	20230322
c3c5823c-3bc3-46c2-bc6a-295b30affa78	Product name	1	20230113
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
6429b384-c989-4e27-bc69-c5e1c7dc2e31	Product name	1	20200304
71c1111b-030c-4ada-94cb-bf623cfad8ec	Product name	1	20180108
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63020-049-01	2021-08-11	C162847	48780-1	c7ccaba7-260a-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use VELCADE safely and effectively. See full prescribing information for VELCADE. VELCADE ® (bortezomib) for injection, for subcutaneous or intravenous use Initial U.S. Approval: 2003
63020-049-01	2021-07-23	C162847	48780-1	c7ccaba7-260a-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use VELCADE safely and effectively. See full prescribing information for VELCADE. VELCADE ® (bortezomib) for injection, for subcutaneous or intravenous use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63020-049-01	VELCADE	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1		36
63020-049-01	VELCADE	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63020-049-01	EA - Each	63020-049	c6794fba-f637-4fe8-bb31-0a2a1547dce9	1	2012-07-24
63020-049-04	EA - Each	63020-049	c44d1000-202f-44e4-a4ea-06080f50d1f9	1	2019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
bortezomib	ACTIVE INGREDIENT	69G8BD63PP	VELCADE (BORTEZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MILLENNIUM PHARMACEUTICALS, INC.]	23
bortezomib	ACTIVE MOIETY	69G8BD63PP	VELCADE (BORTEZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MILLENNIUM PHARMACEUTICALS, INC.]	23
mannitol	INACTIVE INGREDIENT	3OWL53L36A	VELCADE (BORTEZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MILLENNIUM PHARMACEUTICALS, INC.]	23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63020-049	VELCADE (BORTEZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]	35	Current NDC, Legacy NDC, 2 package rows	20221102_1521d321-e724-4ffc-adad-34bf4f44fac7.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VELCADE	BORTEZOMIB	Takeda Pharmaceuticals America, Inc.	1521d321-e724-4ffc-adad-34bf4f44fac7	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021602 application number: NDA021602 ndc (product): 63020-049

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
69G8BD63PP	BORTEZOMIB	179324-69-7	BORTEZOMIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402243	bortezomib 3.5 MG Injection	PSN	1521d321-e724-4ffc-adad-34bf4f44fac7	36
402244	VELCADE 3.5 MG Injection	PSN	1521d321-e724-4ffc-adad-34bf4f44fac7	36
402244	bortezomib 3.5 MG Injection [Velcade]	SBD	1521d321-e724-4ffc-adad-34bf4f44fac7	36
402243	bortezomib 3.5 MG Injection	SCD	1521d321-e724-4ffc-adad-34bf4f44fac7	36
402244	Velcade 3.5 MG Injection	SY	1521d321-e724-4ffc-adad-34bf4f44fac7	36

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63020-049-01	63020004901	1 VIAL in 1 CARTON (63020-049-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	1 vial	2003-05-13	0000-00-00	No	No	Current