CEFTRIAXONE

Product NDC: 57297-622
11-digit product format: 572970622
Labeler code: 57297
Product ID: 57297-622_58528d70-4576-4005-a6ac-6c7807920c7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFTRIAXONE
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: LUPIN LIMITED
Application: ANDA065125
Marketing category: ANDA
Marketing start: 2009-06-01
Marketing end: 0000-00-00
Substance: CEFTRIAXONE SODIUM
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57297-622		I	Inactivated by FDA	2026-10-05
excluded package	package	57297-622	57297-622-01	I	Inactivated by FDA	2026-10-05
excluded package	package	57297-622	57297-622-10	I	Inactivated by FDA	2026-10-05

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57297-622-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57297-622-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57297-622-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57297-622-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57297-622-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57297-622-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57297-622-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57297-622-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57297-622-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57297-622-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57297-622-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57297-622-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57297-622-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57297-622-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57297-622-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57297-622-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57297-622-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57297-622-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-622-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-622-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-622-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-622-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-622-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-622-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57297-622-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57297-622-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57297-622-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57297-622-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57297-622-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57297-622-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57297-622-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57297-622-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57297-622-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57297-622-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57297-622-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57297-622-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57297-622-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57297-622-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57297-622-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57297-622-10	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A065125-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30
A065125-002	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30
A065125-003	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30
A065125-004	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065125-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065125-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065125-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065125-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	2003-09-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A065125-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065125-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065125-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065125-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065125-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065125-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065125-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065125-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065125-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065125-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065125-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065125-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065125-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065125-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065125-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065125-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065125-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065125-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065125-003	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065125-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065125-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065125-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065125-003	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065125-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065125-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065125-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065125-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065125-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065125-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065125-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065125-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065125-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065125-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065125-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065125-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065125-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065125-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065125-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065125-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065125-004	AP	1	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
67ae10d0-6c6a-4d52-a629-da83321859b9	Product name	3	20190201
01b0d089-049b-4c6d-8dfe-1bffad9be307	Product name	2	20180807
2d5083fe-71de-4fce-8d67-e9049cba775c	Product name	1	20150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57297-622-01	2020-01-31	C162847	48780-1	9d75b9d0-9a21-f424-e053-dadaa90a57ce	Ceftriaxone for Injection USP, 250 mg, 500 mg, 1 g and 2 g
57297-622-10	2020-01-31	C162847	48780-1	9d75b9d0-9a21-f424-e053-dadaa90a57ce	Ceftriaxone for Injection USP, 250 mg, 500 mg, 1 g and 2 g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57297-622-01	CEFTRIAXONE	1 in 1 BOX	INJECTION, POWDER, FOR SOLUTION	1		1
57297-622-10	CEFTRIAXONE	10 in 1 BOX	INJECTION, POWDER, FOR SOLUTION	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57297-622	CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [LUPIN LIMITED]	1	Legacy NDC, 2 package rows	20160524_bc1cc991-3e16-48a3-8912-73750674143b.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665021	cefTRIAXone 1 GM Injection	PSN	bc1cc991-3e16-48a3-8912-73750674143b	1
1665046	cefTRIAXone 2 GM Injection	PSN	bc1cc991-3e16-48a3-8912-73750674143b	1
309092	cefTRIAXone 250 MG Injection	PSN	bc1cc991-3e16-48a3-8912-73750674143b	1
1665005	cefTRIAXone 500 MG Injection	PSN	bc1cc991-3e16-48a3-8912-73750674143b	1
1665021	ceftriaxone 1000 MG Injection	SCD	bc1cc991-3e16-48a3-8912-73750674143b	1
1665046	ceftriaxone 2000 MG Injection	SCD	bc1cc991-3e16-48a3-8912-73750674143b	1
309092	ceftriaxone 250 MG Injection	SCD	bc1cc991-3e16-48a3-8912-73750674143b	1
1665005	ceftriaxone 500 MG Injection	SCD	bc1cc991-3e16-48a3-8912-73750674143b	1
1665021	ceftriaxone 1 GM (as ceftriaxone sodium) Injection	SY	bc1cc991-3e16-48a3-8912-73750674143b	1
1665046	ceftriaxone 2 GM (as ceftriaxone sodium) Injection	SY	bc1cc991-3e16-48a3-8912-73750674143b	1
309092	ceftriaxone 250 MG (as ceftriaxone sodium) Injection	SY	bc1cc991-3e16-48a3-8912-73750674143b	1
1665005	ceftriaxone 500 MG (as ceftriaxone sodium) Injection	SY	bc1cc991-3e16-48a3-8912-73750674143b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
57297-622-01	57297062201	1 in 1 BOX	Historical
57297-622-10	57297062210	10 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ceftriaxone for Injection USP, 250 mg, 500 mg, 1 g and 2 g	LUPIN LIMITED	2016-05-12	HUMAN PRESCRIPTION DRUG LABEL	1