Ceftriaxone Sodium

Product NDC: 0409-7337
11-digit product format: 004097337
Labeler code: 0409
Product ID: 0409-7337_c4d53472-41a6-428e-8935-f2c611729457
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftriaxone Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hospira, Inc
Application: ANDA065169
Marketing category: ANDA
Marketing start: 2005-05-09
Substance: CEFTRIAXONE SODIUM
Active strength: 250 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	RLD / RS	Approval date
A065169-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09
A065169-002	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09
A065169-003	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09
A065169-004	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065169-001	AP
A065169-002	AP
A065169-003	AP
A065169-004	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065169-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065169-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065169-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065169-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RS	2005-05-09	`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	A065169-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065169-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065169-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065169-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065169-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065169-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065169-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065169-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065169-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065169-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065169-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065169-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065169-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065169-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065169-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065169-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065169-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065169-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065169-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065169-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065169-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065169-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065169-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065169-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065169-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065169-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065169-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065169-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065169-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065169-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065169-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065169-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065169-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065169-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065169-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065169-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065169-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065169-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065169-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065169-004	AP	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ceftriaxone Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFTRIAXONE SODIUM	250 mg/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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309092	Internal RxNorm lookup
1665005	Internal RxNorm lookup
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
19141ccd-e66c-49a2-a794-0616028495a7	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	SPL version
0409-7337-01	Ceftriaxone Sodium	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	21
0409-7337-11	Ceftriaxone Sodium	1 in 1 VIAL, SINGLE-USE	INJECTION, POWDER, FOR SOLUTION	1	21
0409-7337-20	Ceftriaxone Sodium	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	5
0409-7337-21	Ceftriaxone Sodium	1 in 1 VIAL, SINGLE-USE	INJECTION, POWDER, FOR SOLUTION	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-7337-01	EA - Each	0409-7337	91b1d637-ee3b-4cde-be28-8fc35c95ad37	1	2012-07-24
0409-7337-11	EA - Each	0409-7337	85e43c6e-f653-4be5-9928-2853c9b80310	1	2018-08-13
0409-7337-20	EA - Each	0409-7337	7dec083f-7a0d-40cc-90fd-b7b3e43dfb53	1	2018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CEFTRIAXONE SODIUM	ACTIVE INGREDIENT	023Z5BR09K	CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]	16
CEFTRIAXONE	ACTIVE MOIETY	75J73V1629	CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-7337	CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]	20	Current NDC, Legacy NDC, 2 package rows	20240113_03283208-8616-4117-9d2b-aa8046017a4f.zip
0409-7337	CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]	4	Current NDC, Legacy NDC, 2 package rows	20240113_19141ccd-e66c-49a2-a794-0616028495a7.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sportpharm LLC	ddbc3bf6-5bab-4851-ae5a-ef263cd8f255	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	REMEDYREPACK INC.	9c801096-ca61-4b29-a1e1-5f7e7813b191	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	19141ccd-e66c-49a2-a794-0616028495a7	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169 ndc (product): 0409-7337
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	03283208-8616-4117-9d2b-aa8046017a4f	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169 ndc (product): 0409-7337
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Sandoz Inc	de028434-46cf-44f6-8ac6-889c7c6943b3	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	b642877e-0d36-4218-afe9-0a39f35b571d	2024-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	ff8e830a-c288-46fb-9e19-ec2017943c07	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	a25ab5ea-c46d-4562-8f7e-0ccffc2ab069	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065169 application number: ANDA065169

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
023Z5BR09K	CEFTRIAXONE SODIUM	104376-79-6	CEFTRIAXONE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665021	cefTRIAXone 1 GM Injection	PSN	03283208-8616-4117-9d2b-aa8046017a4f	21
1665046	cefTRIAXone 2 GM Injection	PSN	03283208-8616-4117-9d2b-aa8046017a4f	21
309092	cefTRIAXone 250 MG Injection	PSN	03283208-8616-4117-9d2b-aa8046017a4f	21
1665005	cefTRIAXone 500 MG Injection	PSN	03283208-8616-4117-9d2b-aa8046017a4f	21
1665021	ceftriaxone 1000 MG Injection	SCD	03283208-8616-4117-9d2b-aa8046017a4f	21
1665046	ceftriaxone 2000 MG Injection	SCD	03283208-8616-4117-9d2b-aa8046017a4f	21
309092	ceftriaxone 250 MG Injection	SCD	03283208-8616-4117-9d2b-aa8046017a4f	21
1665005	ceftriaxone 500 MG Injection	SCD	03283208-8616-4117-9d2b-aa8046017a4f	21
1665021	ceftriaxone 1 GM (as ceftriaxone sodium) Injection	SY	03283208-8616-4117-9d2b-aa8046017a4f	21
1665046	ceftriaxone 2 GM (as ceftriaxone sodium) Injection	SY	03283208-8616-4117-9d2b-aa8046017a4f	21
309092	ceftriaxone 250 MG (as ceftriaxone sodium) Injection	SY	03283208-8616-4117-9d2b-aa8046017a4f	21
1665005	ceftriaxone 500 MG (as ceftriaxone sodium) Injection	SY	03283208-8616-4117-9d2b-aa8046017a4f	21
309092	cefTRIAXone 250 MG Injection	PSN	1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c	13
309092	ceftriaxone 250 MG Injection	SCD	1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c	13
309092	ceftriaxone 250 MG (as ceftriaxone sodium) Injection	SY	1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c	13
1665021	cefTRIAXone 1 GM Injection	PSN	19141ccd-e66c-49a2-a794-0616028495a7	5
1665046	cefTRIAXone 2 GM Injection	PSN	19141ccd-e66c-49a2-a794-0616028495a7	5
309092	cefTRIAXone 250 MG Injection	PSN	19141ccd-e66c-49a2-a794-0616028495a7	5
1665005	cefTRIAXone 500 MG Injection	PSN	19141ccd-e66c-49a2-a794-0616028495a7	5
1665021	ceftriaxone 1000 MG Injection	SCD	19141ccd-e66c-49a2-a794-0616028495a7	5
1665046	ceftriaxone 2000 MG Injection	SCD	19141ccd-e66c-49a2-a794-0616028495a7	5
309092	ceftriaxone 250 MG Injection	SCD	19141ccd-e66c-49a2-a794-0616028495a7	5
1665005	ceftriaxone 500 MG Injection	SCD	19141ccd-e66c-49a2-a794-0616028495a7	5
1665021	ceftriaxone 1 GM (as ceftriaxone sodium) Injection	SY	19141ccd-e66c-49a2-a794-0616028495a7	5
1665046	ceftriaxone 2 GM (as ceftriaxone sodium) Injection	SY	19141ccd-e66c-49a2-a794-0616028495a7	5
309092	ceftriaxone 250 MG (as ceftriaxone sodium) Injection	SY	19141ccd-e66c-49a2-a794-0616028495a7	5
1665005	ceftriaxone 500 MG (as ceftriaxone sodium) Injection	SY	19141ccd-e66c-49a2-a794-0616028495a7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-7337-01	00409733701	10 VIAL, SINGLE-USE in 1 CARTON (0409-7337-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-7337-11)	2005-05-09	0000-00-00	No	No	Current
0409-7337-11	00409733711	1 in 1 VIAL, SINGLE-USE					Historical
0409-7337-20	00409733720	10 VIAL, SINGLE-USE in 1 CARTON (0409-7337-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-7337-21)	2018-03-19	0000-00-00	No	No	Current
0409-7337-21	00409733721	1 in 1 VIAL, SINGLE-USE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ceftriaxone for Injection, USP	Hospira, Inc	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	21
Ceftriaxone for Injection, USP	Hospira, Inc	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	5
Ceftriaxone for Injection, USP	A-S Medication Solutions	2024-01-31	HUMAN PRESCRIPTION DRUG LABEL	13
Ceftriaxone for Injection, USP	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
Ceftriaxone for Injection, USP	REMEDYREPACK INC.	2019-03-11	HUMAN PRESCRIPTION DRUG LABEL	1
Ceftriaxone for Injection, USP	NuCare Pharmceuticals,Inc. \| NuCare Pharmaceuticals,Inc.	2017-09-14	HUMAN PRESCRIPTION DRUG LABEL	1