Cefepime

Product NDC: 60505-6145
Requested package NDC: 60505-6145-4
11-digit product format: 605056145
Labeler code: 60505
Product ID: 60505-6145_12c44be3-e077-4579-ad2e-868b503eadb5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefepime
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Apotex Corp.
Application: ANDA203704
Marketing category: ANDA
Marketing start: 2017-11-14
Substance: CEFEPIME HYDROCHLORIDE
Active strength: 2 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203704-001	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01
A203704-002	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01
A203704-003	CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203704-002	AP
A203704-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-002	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-003	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203704-001	CEFEPIME HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RS	2016-02-01	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203704-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203704-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203704-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203704-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203704-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203704-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203704-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203704-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203704-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203704-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203704-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203704-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203704-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203704-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203704-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203704-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203704-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203704-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203704-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203704-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203704-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203704-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203704-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203704-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203704-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203704-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203704-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203704-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203704-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203704-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203704-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203704-002	AP	1	`4b0b4de00fa7…`

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: Cefepime
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFEPIME HYDROCHLORIDE	2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I8X1O0607P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665088	Internal RxNorm lookup
1665093	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
d63d360a-15ec-44a4-b80d-b2a5cb5759eb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4878f213-798f-d240-b895-da945519fdac	Product name	5	20250221
2c48ebbc-4556-4270-89c4-74bed6fedfea	Product name	1	20250117
c050dd27-f8ee-4d60-beb5-08930938e02e	Product name	1	20231115
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
61f3932f-d389-4aed-124d-cf14f88e190f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-6145-4	Cefepime	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	1		7
60505-6145-4	Cefepime	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-6145-4	EA - Each	60505-6145	b9c583fc-94f1-4030-a709-0f106e4da212	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-6145	CEFEPIME INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]	7	Current NDC, Legacy NDC, 2 package rows	20230512_d63d360a-15ec-44a4-b80d-b2a5cb5759eb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefepime	CEFEPIME	Apotex Corp.	d63d360a-15ec-44a4-b80d-b2a5cb5759eb	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203704 application number: ANDA203704 ndc (package): 60505-6145-4 ndc (product): 60505-6145 ndc11 (package): 60505614504
Cefepime	CEFEPIME	Apotex Corp.	02aa374f-37b4-456a-b5de-cfd3bbb6ce6e	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203704 application number: ANDA203704
Cefepime	CEFEPIME	Apotex Corp.	dd641c7f-b857-48ff-bd9d-747e0c3cc89f	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203704 application number: ANDA203704
Cefepime	CEFEPIME HYDROCHLORIDE	Qilu Pharmaceutical Co., Ltd.	80b4c811-4a71-47fb-8565-85ce9d0f782c	2021-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203704 application number: ANDA203704

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I8X1O0607P	CEFEPIME HYDROCHLORIDE	123171-59-5	CEFEPIME HYDROCHLORIDE
807PW4VQE3	CEFEPIME	88040-23-7	Cefepime

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665093	cefepime 1 GM Injection	PSN	d63d360a-15ec-44a4-b80d-b2a5cb5759eb	7
1665088	cefepime 2 GM Injection	PSN	d63d360a-15ec-44a4-b80d-b2a5cb5759eb	7
1665093	cefepime 1000 MG Injection	SCD	d63d360a-15ec-44a4-b80d-b2a5cb5759eb	7
1665088	cefepime 2000 MG Injection	SCD	d63d360a-15ec-44a4-b80d-b2a5cb5759eb	7
1665093	cefepime 1 GM (as cefepime HCl) Injection	SY	d63d360a-15ec-44a4-b80d-b2a5cb5759eb	7
1665088	cefepime 2 GM (as cefepime HCl) Injection	SY	d63d360a-15ec-44a4-b80d-b2a5cb5759eb	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-6145-4	60505614504	10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6145-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2017-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefepime	Apotex Corp. \| Qilu Pharmaceutical Co., Ltd. \| Qilu Pharmaceutical Co., Ltd. (High-Tech Zone Site) \| Qilu Antibiotics Pharmaceutical Co., Ltd.	2023-05-10	HUMAN PRESCRIPTION DRUG LABEL	7