Daptomycin

Product NDC: 16714-892
11-digit product format: 167140892
Labeler code: 16714
Product ID: 16714-892_92b0bfe9-7694-3806-12c2-9d9b4f6ddfa7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Daptomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: NorthStar RxLLC
Application: ANDA208375
Marketing category: ANDA
Marketing start: 2022-06-13
Marketing end: 2026-06-30
Substance: DAPTOMYCIN
Active strength: 50 mg/mL
Pharmacologic classes: Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag: No
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	16714-892		D	Discontinued by firm		2026-08-10
excluded package	package	16714-892	16714-892-01	D	Discontinued by firm		2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208375-001	DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP		2019-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208375-001	AP

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
2026-02-19 14:30 UTC	2026-02	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208375-001	DAPTOMYCIN	500MG/VIAL	POWDER / INTRAVENOUS	AP	2019-05-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208375-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208375-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208375-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208375-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208375-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208375-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208375-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208375-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208375-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208375-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208375-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208375-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208375-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208375-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208375-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208375-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208375-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208375-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208375-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208375-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208375-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208375-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208375-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208375-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208375-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208375-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208375-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208375-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208375-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208375-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208375-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208375-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208375-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208375-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208375-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208375-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208375-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208375-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208375-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208375-001	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
16714-892-01	Daptomycin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		8
16714-892-01	Daptomycin	15 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	15		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-892-01	EA - Each	16714-892	9dd18d73-be8a-49ed-8be4-76dea73831bc	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-892	DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RXLLC]	8	Current NDC, Legacy NDC, 2 package rows	20241204_1c5dee92-299e-26f6-6332-e6a8fd376526.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daptomycin	DAPTOMYCIN	BluePoint Laboratories	d6c3df37-8481-46c2-8048-199bad37c933	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208375 application number: ANDA208375
Daptomycin	DAPTOMYCIN	Dr.Reddy's Laboratories Inc.,	7e9a1b82-f2ba-b2a4-619c-bea7768263e1	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208375 application number: ANDA208375

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	1c5dee92-299e-26f6-6332-e6a8fd376526	8
403920	daptomycin 500 MG Injection	SCD	1c5dee92-299e-26f6-6332-e6a8fd376526	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-892-01	16714089201	1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-01) / 15 mL in 1 VIAL, SINGLE-DOSE	2022-06-13	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Daptomycin	NorthStar RxLLC \| Dr.Reddy's Laboratories Inc., \| Gland Pharma Limited	2024-11-28	HUMAN PRESCRIPTION DRUG LABEL	8