Application 065259

Type: ANDA
Sponsor: LUPIN

Application Products#

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

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

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
A065259-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2006-05-31
A065259-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065259-001	AB
A065259-002	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 · 82 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	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A065259-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065259-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065259-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065259-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065259-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065259-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065259-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065259-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065259-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065259-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065259-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065259-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065259-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065259-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065259-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065259-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065259-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065259-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065259-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065259-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065259-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065259-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065259-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065259-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065259-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065259-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065259-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065259-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065259-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065259-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065259-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065259-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065259-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065259-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065259-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065259-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065259-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065259-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065259-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065259-002	AB	1	`782e0a99824c…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	3714d558-cbaa-42e8-831b-ffbbc951ebf2	2026-04-21	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	A-S Medication Solutions	17b4e82f-4169-4ab9-bd4a-79781a71e160	2025-12-19	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259 ndc (product): 50090-3723
Cefdinir	CEFDINIR	Lupin Pharmaceuticals, Inc.	7490df67-56c0-4a1c-8533-2107f3e8aea5	2025-09-23	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259 ndc (product): 68180-722 ndc (product): 68180-723
Cefdinir	CEFDINIR	Asclemed USA, Inc.	e90660c8-2714-4592-aeaa-bc9ceb26057c	2025-04-19	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	NuCare Pharmaceuticals, Inc.	2fb43fbe-2c4b-1df9-e063-6394a90a9913	2025-03-06	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	fbd76f8c-e6b8-52f4-e053-6394a90aa7ab	2025-02-04	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
CEFDINIR	CEFDINIR	DIRECT RX	982d0f53-20bc-1cb4-e053-2995a90ad33c	2025-01-22	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259 ndc (product): 72189-043
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	1bbd75ea-5a50-eb00-e063-6394a90a1cec	2024-06-25	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	A-S Medication Solutions	37b5d000-db9e-4b6e-8208-6361e98fb55d	2023-11-01	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259 ndc (product): 50090-6171
Cefdinir	CEFDINIR	Proficient Rx LP	444cd2c4-836d-40d5-a307-d719fe83e763	2022-05-02	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259 ndc (product): 71205-380

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-905	Cefdinir	Cefdinir	Aidarex Pharmaceuticals LLC	ANDA	Current
42254-127	Cefdinir	Cefdinir	Rebel Distributors Corp	ANDA	Current
50090-3723	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-3723	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-3723	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-3723	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-3724	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-3724	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-6171	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
57297-722	Cefdinir	Cefdinir	LUPIN LIMITED	ANDA	Current
57297-723	Cefdinir	Cefdinir	LUPIN LIMITED	ANDA	Current
68180-722	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-722	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-722	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-722	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-723	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-723	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-723	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-723	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68258-3053	Cefdinir	Cefdinir	Dispensing Solutions, Inc.	ANDA	Current
68788-7062	Cefdinir	Cefdinir	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7062	Cefdinir	Cefdinir	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7062	Cefdinir	Cefdinir	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7062	Cefdinir	Cefdinir	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-380	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
71205-380	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
71205-380	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
72189-042	CEFDINIR	CEFDINIR	Direct_Rx	ANDA	Current
72189-043	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-043	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-043	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-043	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8391	ORIG	2006-06-02