CEFEPIME HYDROCHLORIDE

Product NDC: 70594-090
11-digit product format: 705940090
Labeler code: 70594
Product ID: 70594-090_5ceacb56-4bff-4036-aadd-2843c6fe45cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFEPIME HYDROCHLORIDE
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Xellia Pharmaceuticals USA LLC
Application: ANDA212721
Marketing category: ANDA
Marketing start: 2021-01-10
Marketing end: 0000-00-00
Substance: CEFEPIME HYDROCHLORIDE
Active strength: 2 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70594-090		D	Discontinued by firm		2026-09-09
excluded package	package	70594-090	70594-090-02	D	Discontinued by firm		2026-09-09

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 · 4 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
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	70594-090-02	`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	70594-090-02	`367a005e9d99…`	`383a685ebd0f…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212721-001	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2020-07-21
A212721-002	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2020-07-21

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 · 76 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	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-07-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-07-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212721-001	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212721-002	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2020-07-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212721-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212721-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212721-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212721-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212721-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212721-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212721-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212721-002	AP	1	`bb7c543d1eb4…`
2021-03-12 10:30 UTC	2021-03	A212721-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212721-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212721-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212721-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212721-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212721-002	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212721-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212721-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212721-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212721-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212721-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212721-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212721-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212721-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212721-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212721-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212721-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212721-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212721-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212721-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212721-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A212721-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212721-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A212721-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212721-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212721-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212721-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212721-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212721-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212721-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212721-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212721-002	AP	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70594-090-02	2024-12-11	C162847	48780-1	1030e365-6272-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME for injection, for intravenous or intramuscular use Initial U.S. Approval: 1996
70594-090-02	2024-07-30	C162847	48780-1	1030e365-6272-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME for injection, for intravenous or intramuscular use Initial U.S. Approval: 1996
70594-090-02	2024-01-30	C162847	48780-1	1030e365-6272-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME for injection, for intravenous or intramuscular use Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70594-090-01	EA - Each	70594-090	433a91b4-57ce-4c51-a8a5-8410b56cd023	1	2021-12-08
70594-090-02	EA - Each	70594-090	3592fccd-4c45-4fa4-83b3-45c4763d183c	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70594-090	CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]	4	Legacy NDC	20241213_91f72dcf-eb1f-4fc6-b9a2-042424012e3e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I8X1O0607P	CEFEPIME HYDROCHLORIDE	123171-59-5	CEFEPIME HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70594-090-02	70594009002	10 VIAL in 1 CARTON (70594-090-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-090-01)	10 vial	2021-01-10	0000-00-00	No	No	Current