Application 065342

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 250MG BASE/VIAL	No	No
002	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 500MG BASE/VIAL	No	No
003	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 1GM BASE/VIAL	No	No
004	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 2GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 5 of 5 · 176 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
2022-10-28 04:53 UTC	2022-10	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065342-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065342-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065342-003	CEFTRIAXONE	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065342-004	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2008-01-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065342-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065342-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065342-003	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065342-004	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065342-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065342-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065342-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065342-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065342-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065342-004	AP	1	`caaa826d4ba7…`
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…`

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 · 1 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 ndc (product): 72572-062

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9856	Ceftriaxone	Ceftriaxone	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9856	Ceftriaxone	Ceftriaxone	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9857	Ceftriaxone	Ceftriaxone	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9857	Ceftriaxone	Ceftriaxone	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9858	Ceftriaxone	Ceftriaxone	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9858	Ceftriaxone	Ceftriaxone	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9859	Ceftriaxone	ceftriaxone	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9859	Ceftriaxone	ceftriaxone	West-Ward Pharmaceuticals Corp	ANDA	Current
50090-2628	Ceftriaxone	Ceftriaxone	A-S Medication Solutions	ANDA	Current
50090-2628	Ceftriaxone	Ceftriaxone	A-S Medication Solutions	ANDA	Current
55154-7476	Ceftriaxone	Ceftriaxone	Cardinal Health	ANDA	Current
70518-0384	Ceftriaxone	Ceftriaxone	REMEDYREPACK INC.	ANDA	Current
70518-3355	Ceftriaxone	Ceftriaxone	REMEDYREPACK INC.	ANDA	Current
72572-061	Ceftriaxone	Ceftriaxone	Civica, Inc.	ANDA	Current
72572-061	Ceftriaxone	Ceftriaxone	Civica, Inc.	ANDA	Current
72572-061	Ceftriaxone	Ceftriaxone	Civica, Inc.	ANDA	Current
72572-062	Ceftriaxone	Ceftriaxone	Civica, Inc.	ANDA	Current
72572-062	Ceftriaxone	Ceftriaxone	Civica, Inc.	ANDA	Current
72572-062	Ceftriaxone	Ceftriaxone	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44233	ORIG	2008-01-17