Ceftriaxone Sodium

Product NDC: 43858-637
11-digit product format: 438580637
Labeler code: 43858
Product ID: 43858-637_bbfeeeee-4664-4960-aab4-5b968d0ad5af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftriaxone Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz GmbH
Application: ANDA065204
Marketing category: ANDA
Marketing start: 2005-05-03
Marketing end: 0000-00-00
Substance: CEFTRIAXONE SODIUM
Active strength: 2 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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
A065204-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2005-05-03
A065204-002	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2005-05-03

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2005-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION			2005-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065204-001	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065204-002	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065204-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065204-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065204-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065204-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065204-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065204-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065204-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065204-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065204-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065204-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065204-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065204-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065204-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065204-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065204-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065204-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065204-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065204-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065204-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065204-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065204-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065204-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065204-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065204-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065204-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065204-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065204-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065204-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065204-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065204-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065204-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065204-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065204-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065204-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065204-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065204-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065204-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065204-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065204-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065204-002	AP	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	128bb292-d174-4769-b3e6-9f16617f31e3	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065204 application number: ANDA065204
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	9d1f630b-e759-4395-9d01-ddc90e4fea75	2022-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065204 application number: ANDA065204

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43858-637-95	43858063795	10 VIAL, SINGLE-USE in 1 CARTON (43858-637-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE	2018-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ceftriaxone for Injection, USP ADD-Vantage ® Vials	Sandoz GmbH	2017-12-15	HUMAN PRESCRIPTION DRUG LABEL	1

Ceftriaxone Sodium

Orange Book products#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#