Daptomycin

Product NDC: 70594-053
Requested package NDC: 70594-053-01
11-digit product format: 705940053
Labeler code: 70594
Product ID: 70594-053_08352c0c-9494-4a27-bc09-ec6a378df233
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: 2019-03-15
Substance: DAPTOMYCIN
Active strength: 350 mg/7mL
Pharmacologic classes: Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 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.

Additional Listing Data#

Finished product: Yes
Brand name base: Daptomycin
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
97c47c18-985d-4373-88f7-a86ec591ea44	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70594-053-01	Daptomycin	7 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	7		5
70594-053-01	Daptomycin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70594-053-01	EA - Each	70594-053	37d14c04-0efa-444f-8ab0-b25835321a27	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70594-053	DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240410_97c47c18-985d-4373-88f7-a86ec591ea44.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 ndc (package): 70594-053-01 ndc (product): 70594-053 ndc11 (package): 70594005301
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	97c47c18-985d-4373-88f7-a86ec591ea44	5
1996246	daptomycin 350 MG Injection	SCD	97c47c18-985d-4373-88f7-a86ec591ea44	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70594-053-01	70594005301	1 VIAL, SINGLE-USE in 1 CARTON (70594-053-01) / 7 mL in 1 VIAL, SINGLE-USE	2019-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Daptomycin	Xellia Pharmaceuticals USA LLC \| Xellia Pharmaceuticals ApS	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL	5