Ceftriaxone

Product NDC: 70518-3355
Requested package NDC: 70518-3355-0
11-digit product format: 705183355
Labeler code: 70518
Product ID: 70518-3355_d7c1d243-71cc-5b75-e053-2a95a90a5dbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftriaxone
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA065342
Marketing category: ANDA
Marketing start: 2022-02-02
Marketing end: 0000-00-00
Substance: CEFTRIAXONE SODIUM
Active strength: 1 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3355	70518-3355-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065342-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10
A065342-002	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10
A065342-003	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10
A065342-004	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A065342-001	AP
A065342-002	AP
A065342-003	AP
A065342-004	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A065342-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065342-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065342-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065342-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065342-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065342-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065342-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065342-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065342-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065342-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065342-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065342-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065342-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065342-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065342-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065342-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065342-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065342-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065342-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065342-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065342-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065342-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065342-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065342-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065342-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065342-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065342-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065342-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065342-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065342-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065342-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065342-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065342-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065342-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065342-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065342-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065342-004	AP	1	`d8e5a09893c0…`

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	CEFTRIAXONE	Civica, Inc.	96f3fc1e-84f4-4e9b-91ac-19a1692f227a	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065342 application number: ANDA065342
Ceftriaxone	CEFTRIAXONE	Hikma Pharmaceuticals USA Inc.	8351aa37-552d-471d-b293-c564dcb6ec29	2021-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065342 application number: ANDA065342

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
023Z5BR09K	CEFTRIAXONE SODIUM	104376-79-6	CEFTRIAXONE SODIUM
75J73V1629	CEFTRIAXONE	73384-59-5	Ceftriaxone

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3355-0	70518335500	25 VIAL in 1 BOX (70518-3355-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70518-3355-1)	25 vial	2022-02-02	0000-00-00	No	No	Current