Daptomycin

Product NDC: 0143-9456
Requested package NDC: 0143-9456-01
11-digit product format: 001439456
Labeler code: 0143
Product ID: 0143-9456_8aa40ade-a628-428b-898c-076d94c40940
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: daptomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA217415
Marketing category: NDA
Marketing start: 2025-12-11
Substance: DAPTOMYCIN
Active strength: 350 mg/7mL
Pharmacologic classes: Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217415-001	DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-01-30
N217415-002	DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-01-30

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217415-001	11759497	2038-08-28		Drug product	2023-10-12
N217415-001	12053502	2038-08-28	U-3981		2024-09-04
N217415-001	12629337	2043-01-09		Drug product	2026-06-10
N217415-002	11759497	2038-08-28		Drug product	2023-10-12
N217415-002	12053502	2038-08-28	U-3981		2024-09-04
N217415-002	12629337	2043-01-09		Drug product	2026-06-10

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 · 50 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	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217415-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217415-002	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2023-01-30	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 76 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	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217415-001	12629337	2043-01-09		Drug product	2026-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217415-002	12629337	2043-01-09		Drug product	2026-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217415-001	12629337	2043-01-09		Drug product	2026-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217415-002	12629337	2043-01-09		Drug product	2026-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217415-001	11759497	2038-08-28		Drug product	2023-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217415-001	12053502	2038-08-28	U-3981		2024-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217415-002	11759497	2038-08-28		Drug product	2023-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217415-002	12053502	2038-08-28	U-3981		2024-09-04	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Daptomycin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPTOMYCIN	350 mg/7mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NWQ5N31VKK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403920	Internal RxNorm lookup
1996246	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
74176769-b22e-4e41-8c56-051e15ec5fea	Available on FDA.report

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9456-01	Daptomycin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		7
0143-9456-01	Daptomycin	7 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	7		7

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daptomycin	DAPTOMYCIN	Civica, Inc.	1ae55ae0-d20f-4e15-b4dc-7e45c33f3152	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217415 application number: NDA217415
Daptomycin	DAPTOMYCIN	Hikma Pharmaceuticals USA Inc.	74176769-b22e-4e41-8c56-051e15ec5fea	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217415 application number: NDA217415 ndc (package): 0143-9456-01 ndc (product): 0143-9456 ndc11 (package): 00143945601
Daptomycin	DAPTOMYCIN	Xellia Pharmaceuticals USA LLC	5e1f739a-eb81-43d8-9a14-89f32b7e1ba1	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217415 application number: NDA217415

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
1996246	DAPTOmycin 350 MG Injection	PSN	74176769-b22e-4e41-8c56-051e15ec5fea	7
403920	DAPTOmycin 500 MG Injection	PSN	74176769-b22e-4e41-8c56-051e15ec5fea	7
1996246	daptomycin 350 MG Injection	SCD	74176769-b22e-4e41-8c56-051e15ec5fea	7
403920	daptomycin 500 MG Injection	SCD	74176769-b22e-4e41-8c56-051e15ec5fea	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0143-9456-01	00143945601	1 VIAL, SINGLE-USE in 1 CARTON (0143-9456-01) / 7 mL in 1 VIAL, SINGLE-USE	2025-12-11	No	No	Current