CEFEPIME HYDROCHLORIDE AND DEXTROSE

Product NDC: 0264-3195
11-digit product format: 002643195
Labeler code: 0264
Product ID: 0264-3195_8b4b5fb9-6be2-40c8-a8ef-60a9d7967e3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFEPIME HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: B. Braun Medical Inc.
Application: NDA050821
Marketing category: NDA
Marketing start: 2010-05-06
Substance: CEFEPIME HYDROCHLORIDE
Active strength: 2 g/50mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS	2010-05-06
N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		RLD, RS	2010-05-06

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2010-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050821-001	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050821-002	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2010-05-06	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: CEFEPIME HYDROCHLORIDE AND DEXTROSE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFEPIME HYDROCHLORIDE	2 g/50mL

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
57517a0e-ec1b-4605-a7cc-7e3801158ec9	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
0264-3195-11	CEFEPIME HYDROCHLORIDE AND DEXTROSE	24 in 1 CASE	INJECTION, SOLUTION	24		25
0264-3195-11	CEFEPIME HYDROCHLORIDE AND DEXTROSE	50 mL in 1 CONTAINER	INJECTION, SOLUTION	50		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-3195-11	EA - Each	0264-3195	acce2005-9452-4aa9-9edb-593455825f31	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFEPIME HYDROCHLORIDE	ACTIVE INGREDIENT	I8X1O0607P	CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	18
CEFEPIME	ACTIVE MOIETY	807PW4VQE3	CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	18
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	18
WATER	INACTIVE INGREDIENT	059QF0KO0R	CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0264-3195	CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]	23	Current NDC, Legacy NDC, 2 package rows	20220402_57517a0e-ec1b-4605-a7cc-7e3801158ec9.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
CEFEPIME HYDROCHLORIDE AND DEXTROSE	CEFEPIME HYDROCHLORIDE	B. Braun Medical Inc.	57517a0e-ec1b-4605-a7cc-7e3801158ec9	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050821 application number: NDA050821 ndc (product): 0264-3195

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665093	cefepime 1 GM Injection	PSN	57517a0e-ec1b-4605-a7cc-7e3801158ec9	25
1665088	cefepime 2 GM Injection	PSN	57517a0e-ec1b-4605-a7cc-7e3801158ec9	25
1665093	cefepime 1000 MG Injection	SCD	57517a0e-ec1b-4605-a7cc-7e3801158ec9	25
1665088	cefepime 2000 MG Injection	SCD	57517a0e-ec1b-4605-a7cc-7e3801158ec9	25
1665093	cefepime 1 GM (as cefepime HCl) Injection	SY	57517a0e-ec1b-4605-a7cc-7e3801158ec9	25
1665088	cefepime 2 GM (as cefepime HCl) Injection	SY	57517a0e-ec1b-4605-a7cc-7e3801158ec9	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0264-3195-11	00264319511	24 CONTAINER in 1 CASE (0264-3195-11) / 50 mL in 1 CONTAINER	24 container	2010-05-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFEPIME HYDROCHLORIDE AND DEXTROSE	B. Braun Medical Inc.	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	25