Application 206829

Type: NDA
Sponsor: CUBIST PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZERBAXA	CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM	POWDER;INTRAVENOUS	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N206829-001	ZERBAXA	CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2014-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 56 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206829-001	7129232	2028-05-15	U-1676	Drug substance, Drug product	2015-01-13
N206829-001	7129232	2028-05-15	U-3360	Drug substance, Drug product	2015-01-13
N206829-001	7129232	2028-05-15	U-3361	Drug substance, Drug product	2015-01-13
N206829-001	7129232	2028-05-15	U-36	Drug substance, Drug product	2015-01-13
N206829-001	7129232	2028-05-15	U-4542	Drug substance, Drug product	2015-01-13
N206829-001	7129232	2028-05-15	U-4543	Drug substance, Drug product	2015-01-13
N206829-001	7129232	2028-05-15	U-4547	Drug substance, Drug product	2015-01-13
N206829-001	7129232	2028-05-15	U-4550	Drug substance, Drug product	2015-01-13
N206829-001	7129232*PED	2028-11-15		Pediatric extension
N206829-001	10028963	2032-09-07	U-2565		2019-07-01
N206829-001	10028963	2032-09-07	U-2566		2019-07-01
N206829-001	10028963	2032-09-07	U-4542		2019-07-01
N206829-001	10028963	2032-09-07	U-4543		2019-07-01
N206829-001	9724353	2032-09-07	U-2565		2019-07-01
N206829-001	9724353	2032-09-07	U-2566		2019-07-01
N206829-001	9724353	2032-09-07	U-4542		2019-07-01
N206829-001	9724353	2032-09-07	U-4543		2019-07-01
N206829-001	10028963*PED	2033-03-07		Pediatric extension
N206829-001	9724353*PED	2033-03-07		Pediatric extension
N206829-001	10420841	2034-03-14	U-1672		2019-10-21
N206829-001	10420841	2034-03-14	U-2631		2019-10-21
N206829-001	10420841	2034-03-14	U-3360		2019-10-21
N206829-001	10420841	2034-03-14	U-3361		2019-10-21
N206829-001	10420841	2034-03-14	U-4546		2019-10-21
N206829-001	10420841	2034-03-14	U-4547		2019-10-21
N206829-001	11278622	2034-03-14	U-3335		2022-04-11
N206829-001	11278622	2034-03-14	U-3336		2022-04-11
N206829-001	11278622	2034-03-14	U-4542		2022-04-11
N206829-001	11278622	2034-03-14	U-4543		2022-04-11
N206829-001	8968753	2034-03-14	U-1672		2015-03-31
N206829-001	8968753	2034-03-14	U-1673		2015-03-31
N206829-001	8968753	2034-03-14	U-3360		2015-03-31
N206829-001	8968753	2034-03-14	U-3361		2015-03-31
N206829-001	8968753	2034-03-14	U-4547		2015-03-31
N206829-001	8968753	2034-03-14	U-4550		2015-03-31
N206829-001	9320740	2034-03-14		Drug product	2016-05-25
N206829-001	9872906	2034-03-14		Drug product	2018-02-08
N206829-001	8906898	2034-05-28		Drug substance, Drug product	2015-01-13
N206829-001	10376496	2034-09-09	U-2610		2019-08-30
N206829-001	10376496	2034-09-09	U-2611		2019-08-30
N206829-001	10376496	2034-09-09	U-4548		2019-08-30
N206829-001	10376496	2034-09-09	U-4549		2019-08-30
N206829-001	10933053	2034-09-09	U-3090		2021-03-23
N206829-001	10933053	2034-09-09	U-3091		2021-03-23
N206829-001	10933053	2034-09-09	U-4544		2021-03-23
N206829-001	10933053	2034-09-09	U-4545		2021-03-23
N206829-001	10420841*PED	2034-09-14		Pediatric extension
N206829-001	11278622*PED	2034-09-14		Pediatric extension
N206829-001	8968753*PED	2034-09-14		Pediatric extension
N206829-001	9320740*PED	2034-09-14		Pediatric extension
N206829-001	9872906*PED	2034-09-14		Pediatric extension
N206829-001	8906898*PED	2034-11-28		Pediatric extension
N206829-001	10376496*PED	2035-03-09		Pediatric extension
N206829-001	10933053*PED	2035-03-09		Pediatric extension
N206829-001	10125149	2035-08-14		Drug product	2018-11-28
N206829-001	10125149*PED	2036-02-14		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N206829-001	NPP	2029-05-12
N206829-001	PED	2029-11-12

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206829-001	ZERBAXA	EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-12-19	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,164 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	N206829-001	7129232	2028-05-15	U-36	Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	7129232	2028-05-15	U-1676	Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	7129232	2028-05-15	U-3361	Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	7129232	2028-05-15	U-3360	Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	7129232	2028-05-15	U-4550	Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	7129232	2028-05-15	U-4547	Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	7129232	2028-05-15	U-4542	Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	7129232	2028-05-15	U-4543	Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	7129232*PED	2028-11-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10028963	2032-09-07	U-2566		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10028963	2032-09-07	U-2565		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10028963	2032-09-07	U-4542		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10028963	2032-09-07	U-4543		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	9724353	2032-09-07	U-2565		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	9724353	2032-09-07	U-2566		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	9724353	2032-09-07	U-4542		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	9724353	2032-09-07	U-4543		2019-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10028963*PED	2033-03-07		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	9724353*PED	2033-03-07		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10420841	2034-03-14	U-2631		2019-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10420841	2034-03-14	U-1672		2019-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10420841	2034-03-14	U-3361		2019-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10420841	2034-03-14	U-3360		2019-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10420841	2034-03-14	U-4546		2019-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10420841	2034-03-14	U-4547		2019-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	11278622	2034-03-14	U-3335		2022-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	11278622	2034-03-14	U-3336		2022-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	11278622	2034-03-14	U-4542		2022-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	11278622	2034-03-14	U-4543		2022-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	8968753	2034-03-14	U-1673		2015-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	8968753	2034-03-14	U-1672		2015-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	8968753	2034-03-14	U-3361		2015-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	8968753	2034-03-14	U-3360		2015-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	8968753	2034-03-14	U-4550		2015-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	8968753	2034-03-14	U-4547		2015-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	9320740	2034-03-14		Drug product	2016-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	9872906	2034-03-14		Drug product	2018-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	8906898	2034-05-28		Drug substance, Drug product	2015-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10376496	2034-09-09	U-2611		2019-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	10376496	2034-09-09	U-2610		2019-08-30	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N206829-001	NPP	2029-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206829-001	PED	2029-11-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206829-001	NPP	2029-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206829-001	PED	2029-11-12	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206829-001	NPP	2025-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206829-001	NPP	2025-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206829-001	NPP	2025-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206829-001	NPP	2025-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206829-001	NCE	2019-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206829-001	GAIN	2024-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206829-001	NPP	2025-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206829-001	NCE	2019-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206829-001	GAIN	2024-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206829-001	NPP	2025-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206829-001	NCE	2019-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206829-001	GAIN	2024-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206829-001	NPP	2025-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206829-001	NCE	2019-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206829-001	GAIN	2024-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206829-001	NPP	2025-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206829-001	NCE	2019-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206829-001	GAIN	2024-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206829-001	NPP	2025-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206829-001	NCE	2019-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206829-001	GAIN	2024-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206829-001	NPP	2025-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206829-001	NCE	2019-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206829-001	GAIN	2024-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206829-001	NPP	2025-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206829-001	NCE	2019-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206829-001	GAIN	2024-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206829-001	NPP	2025-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206829-001	NCE	2019-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206829-001	GAIN	2024-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206829-001	NPP	2025-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206829-001	NCE	2019-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206829-001	GAIN	2024-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206829-001	NPP	2025-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206829-001	NCE	2019-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206829-001	GAIN	2024-12-19	`5d02ea3f76ae…`

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
ZERBAXA	CEFTOLOZANE AND TAZOBACTAM	Merck Sharp & Dohme LLC	70ac1d90-eff3-4f0b-9f46-5846c571b32f	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206829 application number: NDA206829 ndc (product): 67919-030

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67919-030	ZERBAXA	ceftolozane and tazobactam	Merck Sharp & Dohme Corp.	NDA	Current
67919-030	ZERBAXA	ceftolozane and tazobactam	Merck Sharp & Dohme Corp.	NDA	Current
67919-030	ZERBAXA	ceftolozane and tazobactam	Merck Sharp & Dohme LLC	NDA	Current
67919-030	ZERBAXA	ceftolozane and tazobactam	Merck Sharp & Dohme LLC	NDA	Current
67919-030	ZERBAXA	ceftolozane and tazobactam	Merck Sharp & Dohme Corp.	NDA	Current
67919-030	ZERBAXA	ceftolozane and tazobactam	Merck Sharp & Dohme Corp.	NDA	Current
67919-030	ZERBAXA	ceftolozane and tazobactam	Merck Sharp & Dohme Corp.	NDA	Current
67919-030	ZERBAXA	ceftolozane and tazobactam	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85934	SUPPL	2026-05-18
85902	SUPPL	2026-05-13
72840	SUPPL	2022-12-09
70805	SUPPL	2022-04-22
70804	SUPPL	2022-04-22
70803	SUPPL	2022-04-22
70802	SUPPL	2022-04-22
61310	SUPPL	2019-12-17
61278	SUPPL	2019-12-16
58976	SUPPL	2019-06-05
58975	SUPPL	2019-06-05
45768	SUPPL	2016-11-01
45697	SUPPL	2016-10-28
45241	SUPPL	2016-09-06
45237	SUPPL	2016-09-06
10598	SUPPL	2015-05-22
40567	SUPPL	2015-05-20
44950	ORIG	2015-01-27
23026	ORIG	2015-01-27
10597	ORIG	2014-12-23
40566	ORIG	2014-12-22