Ceftriaxone Sodium

Product NDC: 43858-635
11-digit product format: 438580635
Labeler code: 43858
Product ID: 43858-635_141ccc03-28e2-43ec-ac2e-3e77ad2958bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftriaxone Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz GmbH
Application: ANDA065168
Marketing category: ANDA
Marketing start: 2005-05-17
Marketing end: 0000-00-00
Substance: CEFTRIAXONE SODIUM
Active strength: 10 g/100mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065168-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065168-001	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 2 · 42 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	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065168-001	CEFTRIAXONE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-05-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065168-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065168-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065168-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065168-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065168-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065168-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065168-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065168-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065168-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065168-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065168-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065168-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065168-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065168-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065168-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065168-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065168-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065168-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065168-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065168-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065168-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065168-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065168-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065168-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065168-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065168-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065168-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065168-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065168-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065168-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065168-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065168-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065168-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065168-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065168-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065168-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065168-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065168-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065168-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065168-001	AP	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	365fc265-8e6c-432f-9fda-911f5f7fb451	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065168 application number: ANDA065168
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	36c07ebf-b091-483e-b2c4-f0fc0c2b4186	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065168 application number: ANDA065168
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sandoz Inc	53df951b-2eee-44b1-bae2-df7ed85bc0ed	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065168 application number: ANDA065168

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
43858-635-00	43858063500	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (43858-635-00) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	2018-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ceftriaxone for Injection, USP	Sandoz GmbH \| Qilu Antibiotics Pharmaceutical Co., Ltd.	2017-12-18	HUMAN PRESCRIPTION DRUG LABEL	1