daptomycin

Product NDC: 69097-850
11-digit product format: 690970850
Labeler code: 69097
Product ID: 69097-850_219e8987-0f88-4149-80e3-77d97e555791
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: daptomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Cipla USA Inc.
Application: ANDA213425
Marketing category: ANDA
Marketing start: 2021-03-26
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: 2022-12-31
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	69097-850		D	Discontinued by firm		2026-08-10
excluded package	package	69097-850	69097-850-67	D	Discontinued by firm		2026-08-10

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69097-850		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69097-850	69097-850-67	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A213425-001	DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP		2020-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213425-001	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.

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	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	AP	2020-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	AP	2020-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	AP	2020-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / IV (INFUSION)	AP	2020-08-20	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213425-001	DAPTOMYCIN	350MG/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213425-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213425-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213425-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213425-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213425-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213425-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213425-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213425-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213425-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213425-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213425-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213425-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213425-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213425-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213425-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213425-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213425-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213425-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213425-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213425-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213425-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213425-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213425-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213425-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213425-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213425-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213425-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213425-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213425-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213425-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213425-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213425-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213425-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213425-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213425-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213425-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213425-001	AP	1	`a50c72e98297…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-850-67	EA - Each	69097-850	09c4d611-b6a4-42ba-a232-a6db41bf4343	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-850	DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIPLA USA INC.]	1	Legacy NDC	20210327_219e8987-0f88-4149-80e3-77d97e555791.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
daptomycin	DAPTOMYCIN	BE Pharmaceuticals Inc.	c305bc9f-8aeb-40de-8492-154929764daf	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213425 application number: ANDA213425

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NWQ5N31VKK	DAPTOMYCIN	103060-53-3	DAPTOMYCIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-850-67	69097085067	1 VIAL in 1 CARTON (69097-850-67) > 7 mL in 1 VIAL	1 vial	2021-03-26	0000-00-00	No	No	Current