CUBICIN RF

Product NDC: 67919-012
Requested package NDC: 67919-012-01
11-digit product format: 679190012
Labeler code: 67919
Product ID: 67919-012_12165af7-0ba8-4dd6-a13c-9ac832e7fe8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Daptomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Merck Sharp & Dohme LLC
Application: NDA021572
Marketing category: NDA
Marketing start: 2016-09-13
Marketing end: 0000-00-00
Substance: DAPTOMYCIN
Active strength: 500 mg/10mL
Pharmacologic classes: Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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N021572-001	CUBICIN	DAPTOMYCIN	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		2003-09-12
N021572-002	CUBICIN	DAPTOMYCIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2003-09-12
N021572-003	CUBICIN RF	DAPTOMYCIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2016-07-06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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
45ca3ac7-6ee8-4e99-92a6-dc0b401e151a	Product name	1	20250724
223d8260-7a4e-4ebd-9635-845422d6a8ad	Product name	9	20240909
ca803a62-3799-476f-bbc6-024f77cb0320	Product name	4	20240207
cad85d83-8fb9-49f8-a5a6-a399af412964	Product name	1	20230922
8e59a5ed-f224-4156-b534-1ae4d0b6dfd7	Product name	1	20230721
ea2c89ab-e8f8-425f-9693-c923fa1e1703	Product name	1	20220929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67919-012-01	CUBICIN RF	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		22
67919-012-01	CUBICIN RF	10 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	10		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67919-012-02	EA - Each	67919-012	a2ff6da3-4411-49f3-98a9-a2049a62f317	1	2016-10-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NWQ5N31VKK	DAPTOMYCIN	103060-53-3	DAPTOMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
404652	CUBICIN 500 MG Injection	PSN	0b1a8885-2198-4a0e-8105-0c76c1cba6c2	22
403920	DAPTOmycin 500 MG Injection	PSN	0b1a8885-2198-4a0e-8105-0c76c1cba6c2	22
404652	daptomycin 500 MG Injection [Cubicin]	SBD	0b1a8885-2198-4a0e-8105-0c76c1cba6c2	22
403920	daptomycin 500 MG Injection	SCD	0b1a8885-2198-4a0e-8105-0c76c1cba6c2	22
404652	Cubicin 500 MG Injection	SY	0b1a8885-2198-4a0e-8105-0c76c1cba6c2	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67919-012-01	67919001201	1 VIAL, SINGLE-USE in 1 CARTON (67919-012-01) > 10 mL in 1 VIAL, SINGLE-USE	2016-07-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CUBICIN RF	Merck Sharp & Dohme LLC	2025-03-17	HUMAN PRESCRIPTION DRUG LABEL	22
CUBICIN RF	Merck Sharp & Dohme LLC	2022-11-22	HUMAN PRESCRIPTION DRUG LABEL	12