Daptomycin

Product NDC: 0143-9378
11-digit product format: 001439378
Labeler code: 0143
Product ID: 0143-9378_27119712-3c58-4713-9672-b4128b4c678f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Daptomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA212022
Marketing category: ANDA
Marketing start: 2020-01-01
Substance: DAPTOMYCIN
Active strength: 500 mg/10mL
Pharmacologic classes: Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0143-9378		D	Discontinued by firm		2026-08-17
excluded package	package	0143-9378	0143-9378-01	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212022-001	DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS			2019-08-22

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2019-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS		2019-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212022-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-08-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212022-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212022-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212022-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212022-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212022-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212022-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212022-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212022-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212022-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212022-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212022-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212022-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212022-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212022-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212022-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212022-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212022-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212022-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212022-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212022-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212022-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212022-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212022-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212022-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212022-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212022-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212022-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212022-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212022-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212022-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212022-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212022-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212022-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212022-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212022-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212022-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212022-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212022-001	AP	1	`cb3db0bc1861…`

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
0143-9378-01	Daptomycin	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	10		10
0143-9378-01	Daptomycin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9378-01	EA - Each	0143-9378	86c57ae6-8d66-4f3b-b542-4ff106e6ec4e	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9378	DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20220426_e7972bef-5070-428c-8c80-7ec2fc416a7a.zip

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
403920	DAPTOmycin 500 MG Injection	PSN	e7972bef-5070-428c-8c80-7ec2fc416a7a	10
403920	daptomycin 500 MG Injection	SCD	e7972bef-5070-428c-8c80-7ec2fc416a7a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9378-01	00143937801	1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9378-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2020-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Daptomycin	Hikma Pharmaceuticals USA Inc. \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	10