Application 065253

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEPHALEXIN	CEPHALEXIN	CAPSULE;ORAL	EQ 250MG BASE	No	No
002	CEPHALEXIN	CEPHALEXIN	CAPSULE;ORAL	EQ 500MG BASE	No	No
003	CEPHALEXIN	CEPHALEXIN	CAPSULE;ORAL	EQ 750MG BASE	No	No

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

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
A065253-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16
A065253-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16
A065253-003	CEPHALEXIN	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065253-001	AB
A065253-002	AB
A065253-003	AB

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 3 · 106 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
2026-09-14 22:38:34	2026-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065253-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065253-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065253-001	AB	1	`301d65b070ca…`

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	12f78d76-ea13-440c-8dd0-5aec86277acf	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Cronus Pharma LLC	a4e861e2-5803-4c4a-a962-92f5755e1ab5	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253 ndc (product): 69043-008 ndc (product): 69043-009
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	8e28f049-6110-4473-830f-c494191a7197	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253 ndc (product): 65862-019 ndc (product): 65862-018
Cephalexin	CEPHALEXIN	A-S Medication Solutions	99ef59d5-bc44-4727-86fe-dc81357207c3	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253 ndc (product): 50090-0079 ndc (product): 50090-0070
Cephalexin	CEPHALEXIN	A-S Medication Solutions	65b38519-1d8a-4aca-b415-c64cca84d085	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals, Inc.	216660f3-0329-ef7d-e063-6294a90a17df	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Proficient Rx LP	e43271ef-c145-4145-b7f0-a02c237de2b5	2024-08-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af49507d-254f-296d-e053-2a95a90ad263	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253 ndc (product): 80425-0004
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	f957ea27-2906-40c7-ac03-eb2f742473a0	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253

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 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-7244	Cephalexin	Cephalexin	Liberty Pharmaceuticals, Inc.	ANDA	Current
10544-004	Cephalexin	Cephalexin	Blenheim Pharmacal, Inc.	ANDA	Current
10544-142	Cephalexin	Cephalexin	Blenheim Pharmacal, Inc.	ANDA	Current
21695-316	Cephalexin	Cephalexin	Rebel Distributors Corp.	ANDA	Current
21695-317	Cephalexin	Cephalexin	Rebel Distributors Corp.	ANDA	Current
45865-428	Cephalexin	Cephalexin	Medsource Pharmaceuticals	ANDA	Current
45865-428	Cephalexin	Cephalexin	Medsource Pharmaceuticals	ANDA	Current
50090-0070	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
50090-0070	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
50090-0079	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
50090-0081	Cephalexin	Cephalexin	A-S Medication Solutions	ANDA	Current
51655-026	Cephalexin	Cephalexin	Northwind Pharmaceuticals, LLC	ANDA	Current
52343-001	Cephalexin	Cephalexin	Gen-Source Rx	ANDA	Current
52343-002	Cephalexin	Cephalexin	Gen-Source Rx	ANDA	Current
55700-043	Cephalexin	Cephalexin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-145	Cephalexin	Cephalexin	Quality Care Products, LLC	ANDA	Current
65862-018	Cephalexin	Cephalexin	Aurobindo Pharma Limited	ANDA	Current
65862-018	Cephalexin	Cephalexin	Aurobindo Pharma Limited	ANDA	Current
65862-018	Cephalexin	Cephalexin	Aurobindo Pharma Limited	ANDA	Current
65862-018	Cephalexin	Cephalexin	Aurobindo Pharma Limited	ANDA	Current
65862-019	Cephalexin	Cephalexin	Aurobindo Pharma Limited	ANDA	Current
65862-019	Cephalexin	Cephalexin	Aurobindo Pharma Limited	ANDA	Current
65862-019	Cephalexin	Cephalexin	Aurobindo Pharma Limited	ANDA	Current
65862-019	Cephalexin	Cephalexin	Aurobindo Pharma Limited	ANDA	Current
66116-400	Cephalexin	Cephalexin	MedVantx, Inc.	ANDA	Current
66336-055	Cephalexin	Cephalexin	Dispensing Solutions, Inc.	ANDA	Current
68788-9404	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9404	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9404	Cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
69043-008	Cephalexin	Cephalexin	Cronus Pharma LLC	ANDA	Current
69043-008	Cephalexin	Cephalexin	Cronus Pharma LLC	ANDA	Current
69043-009	Cephalexin	Cephalexin	Cronus Pharma LLC	ANDA	Current
69043-009	Cephalexin	Cephalexin	Cronus Pharma LLC	ANDA	Current
70518-3066	Cephalexin	Cephalexin	REMEDYREPACK INC.	ANDA	Current
70518-3066	Cephalexin	Cephalexin	REMEDYREPACK INC.	ANDA	Current
70518-3066	Cephalexin	Cephalexin	REMEDYREPACK INC.	ANDA	Current
70518-3066	Cephalexin	Cephalexin	REMEDYREPACK INC.	ANDA	Current
70934-109	Cephalexin	Cephalexin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-109	Cephalexin	Cephalexin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
72287-310	Cephalexin	Cephalexin	AMELLA PHARMA, LLC	ANDA	Current
76413-142	Cephalexin	Cephalexin	Central Texas Community Health Centers	ANDA	Current
80425-0004	Cephalexin	Cephalexin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0004	Cephalexin	Cephalexin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current