Application 065234

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEPHALEXIN	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	No	No
002	CEPHALEXIN	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065234-001	CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2005-08-17
A065234-002	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2005-08-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065234-001	AB
A065234-002	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 · 84 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	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A065234-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065234-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065234-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065234-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065234-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065234-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065234-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065234-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065234-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065234-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065234-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065234-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065234-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065234-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065234-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065234-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065234-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065234-002	AB	1	`bb7c543d1eb4…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	25ef498a-7a7e-4543-a544-b9d0e99f9cd9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234 ndc (product): 68180-123 ndc (product): 68180-440 ndc (product): 68180-441 ndc (product): 68180-124
cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	553485f8-890d-4929-a6bb-905221cf411d	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	141bd050-5dfc-68fa-e063-6394a90a6d86	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	A-S Medication Solutions	d31da5be-c939-4aa0-adb8-b26a1396b228	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	Proficient Rx LP	829244bd-93da-4a5a-a257-890cfec4c06d	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234 ndc (product): 71205-553
cephalexin	CEPHALEXIN	A-S Medication Solutions	0a24b6e5-6f13-44b4-93f4-47c86945cad2	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-485	cephalexin	Cephalexin	Aidarex Pharmaceuticals LLC	ANDA	Current
52959-620	Cephalexin	Cephalexin	H.J. Harkins Company, Inc.	ANDA	Current
55700-149	cephalexin	Cephalexin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-656	cephalexin	Cephalexin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-656	cephalexin	Cephalexin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-656	cephalexin	Cephalexin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-049	CEPHALEXIN	CEPHALEXIN	DIRECT RX	ANDA	Current
61919-049	CEPHALEXIN	CEPHALEXIN	DIRECT RX	ANDA	Current
68071-5011	cephalexin	Cephalexin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5011	cephalexin	Cephalexin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-123	cephalexin	Cephalexin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-124	cephalexin	Cephalexin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-440	cephalexin	Cephalexin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-440	cephalexin	Cephalexin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-441	cephalexin	Cephalexin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-441	cephalexin	Cephalexin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-7938	cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7938	cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9956	cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9957	cephalexin	Cephalexin	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-553	cephalexin	Cephalexin	Proficient Rx LP	ANDA	Current