Daptomycin

Product NDC: 45932-0039
11-digit product format: 459320039
Labeler code: 45932
Product ID: 45932-0039_124c90b9-3a96-4e66-9818-8088cd70cd86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Daptomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Xellia Pharmaceuticals USA, LLC
Application: NDA209949
Marketing category: NDA
Marketing start: 2018-07-19
Marketing end: 0000-00-00
Substance: DAPTOMYCIN
Active strength: 350 mg/7mL
Pharmacologic classes: Lipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45932-0039		I	Inactivated by FDA		2026-10-05
excluded package	package	45932-0039	45932-0039-1	I	Inactivated by FDA		2026-10-05

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45932-0039-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45932-0039-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45932-0039-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45932-0039-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45932-0039-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45932-0039-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45932-0039-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45932-0039-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45932-0039-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45932-0039-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45932-0039-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45932-0039-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45932-0039-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45932-0039-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45932-0039-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	45932-0039-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	45932-0039-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	45932-0039-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	45932-0039-1	`8dfbde2a14a4…`	`c9ff85d89658…`

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
N209949-001	DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-10-20

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	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	RLD, RS	2017-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	RLD, RS	2017-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	RLD, RS	2017-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	RLD, RS	2017-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	RLD, RS	2017-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	RLD, RS	2017-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	RLD, RS	2017-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	RLD, RS	2017-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209949-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-10-20	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45932-0039-1	2021-01-29	C162847	48780-1	ba0f9c33-3363-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use DAPTOMYCIN FOR INJECTION safely and effectively. See full prescribing information for DAPTOMYCIN FOR INJECTION. DAPTOMYCIN for injection, for intravenous use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45932-0039-1	Daptomycin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		9
45932-0039-1	Daptomycin	7 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	7		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45932-0039	DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA, LLC]	9	Legacy NDC, 2 package rows	20191007_e3e6b91e-c673-46da-a654-2bb1312cb02b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daptomycin	DAPTOMYCIN	Hikma Pharmaceuticals USA Inc.	23f39005-3008-4ab1-918d-b8acb001554e	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209949 application number: NDA209949
Daptomycin	DAPTOMYCIN	Xellia Pharmaceuticals USA LLC	97c47c18-985d-4373-88f7-a86ec591ea44	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209949 application number: NDA209949
Daptomycin	DAPTOMYCIN	Civica, Inc.	bcacf746-a3ee-48b5-bfbe-6a2b548ad24c	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209949 application number: NDA209949

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	e3e6b91e-c673-46da-a654-2bb1312cb02b	9
1996246	daptomycin 350 MG Injection	SCD	e3e6b91e-c673-46da-a654-2bb1312cb02b	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45932-0039-1	45932003901	1 in 1 CARTON	Historical