Application 021572

Type: NDA
Sponsor: CUBIST PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CUBICIN	DAPTOMYCIN	POWDER;INTRAVENOUS	250MG/VIAL	No	No
002	CUBICIN	DAPTOMYCIN	POWDER;INTRAVENOUS	500MG/VIAL	Yes	Yes
003	CUBICIN RF	DAPTOMYCIN	POWDER;INTRAVENOUS	500MG/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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021572-001	CUBICIN	DAPTOMYCIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12
N021572-002	CUBICIN	DAPTOMYCIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12
N021572-003	CUBICIN RF	DAPTOMYCIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021572-002	8003673	2028-09-04	U-1180		2011-09-23
N021572-003	9138456	2030-11-23		Drug product	2016-08-01

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021572-002	CUBICIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021572-003	CUBICIN RF	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021572-001	CUBICIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021572-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021572-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021572-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021572-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021572-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021572-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021572-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021572-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021572-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021572-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021572-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021572-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021572-002	AP	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N021572-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021572-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021572-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021572-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021572-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021572-002	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 86 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	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021572-002	8003673	2028-09-04	U-1180		2011-09-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021572-003	9138456	2030-11-23		Drug product	2016-08-01	`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021572-002	NPP	2020-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021572-002	M-211	2020-09-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021572-003	NPP	2020-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021572-003	M-211	2020-09-01	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021572-002	NPP	2020-03-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021572-002	M-211	2020-09-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021572-003	NPP	2020-03-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021572-003	M-211	2020-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021572-002	NPP	2020-03-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021572-002	M-211	2020-09-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021572-003	NPP	2020-03-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021572-003	M-211	2020-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021572-002	NPP	2020-03-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021572-002	M-211	2020-09-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021572-003	NPP	2020-03-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021572-003	M-211	2020-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021572-002	NPP	2020-03-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021572-002	M-211	2020-09-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021572-003	NPP	2020-03-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021572-003	M-211	2020-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021572-002	NPP	2020-03-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021572-002	M-211	2020-09-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021572-003	NPP	2020-03-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021572-003	M-211	2020-09-01	`ea99ee380514…`

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 3 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
daptomycin	DAPTOMYCIN	Slate Run Pharmaceuticals, LLC	3890474a-4425-43b3-97d4-5370cc35c2f7	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Fresenius Kabi USA, LLC	a990141d-7b92-48a5-a41d-1254522e2aa1	2022-06-09	Warnings, Adverse reactions	Name fallback generic name: DAPTOMYCIN
daptomycin	DAPTOMYCIN	Sagent Pharmaceuticals	f4ad8613-f25e-4b82-9621-cc5ff9525d3e	2022-05-17	Warnings, Adverse reactions	Name fallback generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Hikma Pharmaceuticals USA Inc.	1a7c9f52-7b58-49e9-93d7-5a26a7d1ef09	2022-04-29	Warnings, Adverse reactions	Name fallback generic name: DAPTOMYCIN
DAPZURA RT	DAPTOMYCIN	Baxter Healthcare Corporation	cb1283e1-35b8-425c-b338-d9ac0c7161f8	2022-01-25	Warnings, Adverse reactions	Name fallback generic name: DAPTOMYCIN
Daptomycin	DAPTOMYCIN	Dr. Reddy's Laboratories Inc.,	d750e28d-1353-4671-66a3-ea4e49e81e7b	2021-10-04	Warnings, Adverse reactions	Name fallback generic name: DAPTOMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-0125	Daptomycin	Daptomycin	Teva Parenteral Medicines, Inc.	NDA AUTHORIZED GENERIC	Current
0703-0125	Daptomycin	Daptomycin	Teva Parenteral Medicines, Inc.	NDA AUTHORIZED GENERIC	Current
0703-0125	Daptomycin	Daptomycin	Teva Parenteral Medicines, Inc.	NDA AUTHORIZED GENERIC	Current
0703-0125	Daptomycin	Daptomycin	Teva Parenteral Medicines, Inc.	NDA AUTHORIZED GENERIC	Current
0703-0125	Daptomycin	Daptomycin	Teva Parenteral Medicines, Inc.	NDA AUTHORIZED GENERIC	Current
0703-0125	Daptomycin	Daptomycin	Teva Parenteral Medicines, Inc.	NDA AUTHORIZED GENERIC	Current
0703-0125	Daptomycin	Daptomycin	Teva Parenteral Medicines, Inc.	NDA AUTHORIZED GENERIC	Current
67919-011	Cubicin	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-011	Cubicin	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-011	Cubicin	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-011	Cubicin	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-011	Cubicin	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-011	Cubicin	Daptomycin	Merck Sharp & Dohme LLC	NDA	Current
67919-011	Cubicin	Daptomycin	Merck Sharp & Dohme LLC	NDA	Current
67919-011	Cubicin	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme LLC	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme LLC	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme LLC	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme LLC	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme LLC	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current
67919-012	CUBICIN RF	Daptomycin	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82206	SUPPL	2025-05-21
82195	SUPPL	2025-05-15
82177	SUPPL	2025-05-14
82205	SUPPL	2025-05-12
74717	SUPPL	2023-07-11
70253	SUPPL	2022-02-25
70240	SUPPL	2022-02-24
69142	SUPPL	2021-10-27
69141	SUPPL	2021-10-27
69134	SUPPL	2021-10-27
69133	SUPPL	2021-10-27
64464	SUPPL	2020-09-01
64463	SUPPL	2020-09-01
64427	SUPPL	2020-08-27
64426	SUPPL	2020-08-27
56654	SUPPL	2018-12-07
56624	SUPPL	2018-12-04
51736	SUPPL	2018-01-25
49677	SUPPL	2017-09-06
49676	SUPPL	2017-09-06
49664	SUPPL	2017-09-05
49663	SUPPL	2017-09-05
48701	SUPPL	2017-06-12
48695	SUPPL	2017-06-12
47832	SUPPL	2017-04-03
47831	SUPPL	2017-04-03
47790	SUPPL	2017-03-30
47789	SUPPL	2017-03-30
45789	SUPPL	2016-11-02
45788	SUPPL	2016-11-02
37265	SUPPL	2016-07-18
28157	SUPPL	2016-07-12
37264	SUPPL	2016-07-08
37263	SUPPL	2015-12-03
5768	SUPPL	2015-09-18
5767	SUPPL	2015-08-06
15806	SUPPL	2015-08-04
37262	SUPPL	2014-12-19
5766	SUPPL	2014-11-28
37261	SUPPL	2013-11-26
37260	SUPPL	2013-11-26
28156	SUPPL	2013-11-26
5765	SUPPL	2013-11-26
5764	SUPPL	2012-10-15
15805	SUPPL	2012-10-12
37259	SUPPL	2012-06-18
28155	SUPPL	2012-06-15
28154	SUPPL	2012-05-23
15803	SUPPL	2012-05-23
5763	SUPPL	2011-10-04
15804	SUPPL	2011-10-03
28152	SUPPL	2010-12-10
28153	SUPPL	2010-12-06
28151	SUPPL	2010-12-06
28150	SUPPL	2010-12-06
28149	SUPPL	2010-12-06
28148	SUPPL	2010-12-06
5762	SUPPL	2010-12-06
37258	SUPPL	2010-12-02
37257	SUPPL	2010-12-02
37256	SUPPL	2010-12-02
37255	SUPPL	2010-12-02
15801	SUPPL	2010-12-02
15800	SUPPL	2010-12-02
15802	SUPPL	2010-08-28
5761	SUPPL	2009-02-13
37254	SUPPL	2007-10-10
5760	SUPPL	2007-10-10
37253	SUPPL	2007-08-22
5757	SUPPL	2007-08-22
28147	SUPPL	2007-02-23
5759	SUPPL	2007-02-23
15799	SUPPL	2007-02-21
15798	SUPPL	2007-02-21
28146	SUPPL	2006-11-06
15797	SUPPL	2006-10-25
15796	SUPPL	2006-05-26
5758	SUPPL	2006-05-26
37252	SUPPL	2005-10-19
28145	SUPPL	2005-10-19
21740	ORIG	2003-12-15
37251	ORIG	2003-09-25
5756	ORIG	2003-09-25
62935	SUPPL	1900-01-01
62934	SUPPL	1900-01-01
62933	SUPPL	1900-01-01
62930	SUPPL	1900-01-01
52894	SUPPL	1900-01-01
52892	SUPPL	1900-01-01
52593	SUPPL	1900-01-01
52592	SUPPL	1900-01-01