Ceftriaxone

Product NDC: 72572-061
11-digit product format: 725720061
Labeler code: 72572
Product ID: 72572-061_36b74132-c90c-4cda-bd0c-93855b45e205
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftriaxone
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Civica, Inc.
Application: ANDA065342
Marketing category: ANDA
Marketing start: 2020-03-01
Substance: CEFTRIAXONE SODIUM
Active strength: 1 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 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
2026-02-19 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…`
2024-10-29 15:01 UTC	2024-10	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-10-29 15:01 UTC	2024-10	A065342-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065342-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065342-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065342-004	AP	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ceftriaxone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFTRIAXONE SODIUM	1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
023Z5BR09K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665021	Internal RxNorm lookup
1665046	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
96f3fc1e-84f4-4e9b-91ac-19a1692f227a	Available on FDA.report

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
72572-061-01	Ceftriaxone	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		5
72572-061-25	Ceftriaxone	25 in 1 BOX	INJECTION, POWDER, FOR SOLUTION	25		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72572-061-01	EA - Each	72572-061	39bf9ddc-01b6-4afa-956e-34378de25f2e	1	2020-04-20
72572-061-25	EA - Each	72572-061	3c5d6a03-ad28-4af6-b07a-af5a51d575ba	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72572-061	CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240207_96f3fc1e-84f4-4e9b-91ac-19a1692f227a.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 · 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 ndc (product): 72572-061
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665021	cefTRIAXone 1 GM Injection	PSN	96f3fc1e-84f4-4e9b-91ac-19a1692f227a	5
1665046	cefTRIAXone 2 GM Injection	PSN	96f3fc1e-84f4-4e9b-91ac-19a1692f227a	5
1665021	ceftriaxone 1000 MG Injection	SCD	96f3fc1e-84f4-4e9b-91ac-19a1692f227a	5
1665046	ceftriaxone 2000 MG Injection	SCD	96f3fc1e-84f4-4e9b-91ac-19a1692f227a	5
1665021	ceftriaxone 1 GM (as ceftriaxone sodium) Injection	SY	96f3fc1e-84f4-4e9b-91ac-19a1692f227a	5
1665046	ceftriaxone 2 GM (as ceftriaxone sodium) Injection	SY	96f3fc1e-84f4-4e9b-91ac-19a1692f227a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72572-061-01	72572006101	1 in 1 VIAL						Historical
72572-061-25	72572006125	25 VIAL in 1 BOX (72572-061-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72572-061-01)	25 vial	2020-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFTRIAXONE FOR INJECTION, USP	Civica, Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A.	2024-02-06	HUMAN PRESCRIPTION DRUG LABEL	5