Ceftriaxone

Product NDC: 0338-5002
11-digit product format: 003385002
Labeler code: 0338
Product ID: 0338-5002_e6debc12-1f25-437c-970e-607f4953c7f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftriaxone Sodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: ANDA065224
Marketing category: ANDA
Marketing start: 2005-08-23
Substance: CEFTRIAXONE SODIUM
Active strength: 1 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
A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION		RS	2005-08-23
A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RS	2005-08-23

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	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ceftriaxone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFTRIAXONE SODIUM	1 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
023Z5BR09K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665021	Internal RxNorm lookup
1665046	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
4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
67ae10d0-6c6a-4d52-a629-da83321859b9	Product name	3	20190201
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
01b0d089-049b-4c6d-8dfe-1bffad9be307	Product name	2	20180807
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
2d5083fe-71de-4fce-8d67-e9049cba775c	Product name	1	20150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-5002-41	Ceftriaxone	50 mL in 1 BAG	INJECTION, SOLUTION	50		26
0338-5002-41	Ceftriaxone	24 in 1 CASE	INJECTION, SOLUTION	24		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-5002-41	ML - Milliliter	0338-5002	ed86780a-491b-403a-bdfb-212af90c19c3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFTRIAXONE SODIUM	ACTIVE INGREDIENT	023Z5BR09K	CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	14
CEFTRIAXONE	ACTIVE MOIETY	75J73V1629	CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	14
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	14
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	14
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	14
WATER	INACTIVE INGREDIENT	059QF0KO0R	CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-5002	CEFTRIAXONE (CEFTRIAXONE SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	25	Current NDC, Legacy NDC, 2 package rows	20250522_4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1.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
Ceftriaxone	CEFTRIAXONE SODIUM	Baxter Healthcare Company	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065224 application number: ANDA065224 ndc (product): 0338-5002

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
023Z5BR09K	CEFTRIAXONE SODIUM	104376-79-6	CEFTRIAXONE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665021	cefTRIAXone 1 GM Injection	PSN	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	26
1665046	cefTRIAXone 2 GM Injection	PSN	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	26
1665021	ceftriaxone 1000 MG Injection	SCD	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	26
1665046	ceftriaxone 2000 MG Injection	SCD	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	26
1665021	ceftriaxone 1 GM (as ceftriaxone sodium) Injection	SY	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	26
1665046	ceftriaxone 2 GM (as ceftriaxone sodium) Injection	SY	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-5002-41	00338500241	24 BAG in 1 CASE (0338-5002-41) / 50 mL in 1 BAG	24 bag	2005-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ceftriaxone Injection, USP (In Dextrose) in Galaxy Container	Baxter Healthcare Company \| Baxter Healthcare Corporation	2024-10-07	HUMAN PRESCRIPTION DRUG LABEL	26