Ceftriaxone

Product NDC: 63323-347
11-digit product format: 633230347
Labeler code: 63323
Product ID: 63323-347_901ade23-0896-7fad-e053-2a95a90a09a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftriaxone
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA065329
Marketing category: ANDA
Marketing start: 2011-06-20
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

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	63323-347		D	Discontinued by firm		2026-08-17
excluded package	package	63323-347	63323-347-20	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 · 24 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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`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	63323-347-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065329-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24
A065329-002	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24
A065329-003	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065329-001	AP
A065329-002	AP
A065329-003	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 4 · 126 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	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065329-002	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065329-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065329-001	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2008-07-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A065329-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065329-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065329-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065329-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065329-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065329-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065329-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065329-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065329-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065329-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065329-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065329-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065329-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065329-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065329-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065329-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065329-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065329-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065329-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065329-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065329-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065329-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065329-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065329-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065329-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065329-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065329-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065329-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065329-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065329-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065329-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065329-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065329-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065329-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065329-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065329-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065329-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065329-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065329-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065329-001	AP	1	`1e350fbaab3a…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-347-01	Ceftriaxone	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		6
63323-347-20	Ceftriaxone	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-347-20	EA - Each	63323-347	6f5c20e6-d6f3-4a72-80bd-e8cffc348e16	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CEFTRIAXONE SODIUM	ACTIVE INGREDIENT	023Z5BR09K	CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS , LLC]	1
CEFTRIAXONE	ACTIVE MOIETY	75J73V1629	CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS , LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-347	CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	6	Legacy NDC, 2 package rows	20231021_7ea1db43-40fa-417b-8911-ae98092070a0.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone	CEFTRIAXONE	WG Critical Care, LLC	7bed9b33-29e3-4f04-9766-43a21c7ad47a	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065329 application number: ANDA065329
Ceftriaxone	CEFTRIAXONE	WG Critical Care, LLC	befd73ff-cb3b-4543-8a8e-bdb9b7fc1ff0	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065329 application number: ANDA065329
ceftriaxone	CEFTRIAXONE	Sagent Pharmaceuticals	5cf93bc5-9e4c-4734-bc02-c7d0ac071022	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065329 application number: ANDA065329
Ceftriaxone	CEFTRIAXONE	Fresenius Kabi USA, LLC	7ea1db43-40fa-417b-8911-ae98092070a0	2023-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065329 application number: ANDA065329 ndc (product): 63323-347
Ceftriaxone	CEFTRIAXONE	Proficient Rx LP	fcf401df-bcdc-4773-a63b-9741c0f74b3d	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065329 application number: ANDA065329

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	7ea1db43-40fa-417b-8911-ae98092070a0	6
1665046	cefTRIAXone 2 GM Injection	PSN	7ea1db43-40fa-417b-8911-ae98092070a0	6
1665005	cefTRIAXone 500 MG Injection	PSN	7ea1db43-40fa-417b-8911-ae98092070a0	6
1665021	ceftriaxone 1000 MG Injection	SCD	7ea1db43-40fa-417b-8911-ae98092070a0	6
1665046	ceftriaxone 2000 MG Injection	SCD	7ea1db43-40fa-417b-8911-ae98092070a0	6
1665005	ceftriaxone 500 MG Injection	SCD	7ea1db43-40fa-417b-8911-ae98092070a0	6
1665021	ceftriaxone 1 GM (as ceftriaxone sodium) Injection	SY	7ea1db43-40fa-417b-8911-ae98092070a0	6
1665046	ceftriaxone 2 GM (as ceftriaxone sodium) Injection	SY	7ea1db43-40fa-417b-8911-ae98092070a0	6
1665005	ceftriaxone 500 MG (as ceftriaxone sodium) Injection	SY	7ea1db43-40fa-417b-8911-ae98092070a0	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63323-347-01	63323034701	1 in 1 VIAL	Historical
63323-347-20	63323034720	10 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ceftriaxone for Injection, USP	Fresenius Kabi USA, LLC \| ACS Dobfar SPA	2023-09-30	HUMAN PRESCRIPTION DRUG LABEL	6