Ceftriaxone

Product NDC: 52584-148
11-digit product format: 525840148
Labeler code: 52584
Product ID: 52584-148_d8eb4e2d-bd90-45cd-b6f3-94d4c22424b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftriaxone Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: General Injectables and Vaccines, Inc.
Application: ANDA203702
Marketing category: ANDA
Marketing start: 2019-05-17
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: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52584-148		D	Discontinued by firm		2026-08-17
excluded package	package	52584-148	52584-148-00	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-148-00	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-148-00	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-148-00	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-148-00	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-148-00	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-148-00	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-148-00	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-148-00	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-148-00	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-148-00	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-148-00	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-148-00	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52584-148-00	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52584-148-00	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52584-148-00	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A203702-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29
A203702-002	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29
A203702-003	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29
A203702-004	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203702-001	AP
A203702-002	AP
A203702-003	AP
A203702-004	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	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203702-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203702-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203702-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203702-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2016-06-29	`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	A203702-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203702-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203702-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203702-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203702-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203702-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203702-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203702-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203702-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203702-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203702-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203702-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203702-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203702-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203702-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203702-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203702-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203702-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203702-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203702-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203702-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203702-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203702-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203702-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203702-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203702-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203702-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203702-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203702-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203702-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203702-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203702-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203702-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203702-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203702-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203702-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203702-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203702-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203702-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203702-004	AP	1	`d8e5a09893c0…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52584-148-00	2022-12-14	C162847	48780-1	d6a99b39-a561-a426-e053-dadaa90af4c2	Ceftriaxone for Injection, USP
52584-148-00	2022-01-28	C162847	48780-1	d6a99b39-a561-a426-e053-dadaa90af4c2	Ceftriaxone for Injection, USP

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sportpharm LLC	85ce4f8b-77e0-48bf-9f57-93f1478befa2	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203702 application number: ANDA203702
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sportpharm LLC	9a937e47-8c36-4656-83e1-b3c18ed9bac3	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203702 application number: ANDA203702
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Qilu Pharmaceutical Co., Ltd.	4cdf0743-c62b-4969-b9c9-4c6400644f6c	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203702 application number: ANDA203702
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	53415af6-4072-4339-83e2-d870ae02a0e2	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203702 application number: ANDA203702
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	790279d4-2456-4091-abec-960b78885432	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203702 application number: ANDA203702
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Asclemed USA, Inc.	f01cf0e5-caaf-4759-ba21-50f3aceff523	2023-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203702 application number: ANDA203702
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Apotex Corp.	5116231f-82d1-44be-b08e-560c9a50e5c5	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203702 application number: ANDA203702
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	42ba7a9d-7d2b-4eac-af59-897151a8c924	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203702 application number: ANDA203702

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
52584-148-00	52584014800	1 VIAL, SINGLE-USE in 1 BAG (52584-148-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE	2019-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ceftriaxone for Injection, USP	General Injectables and Vaccines, Inc.	2020-05-07	HUMAN PRESCRIPTION DRUG LABEL	2