Application 065264

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFDINIR	CEFDINIR	CAPSULE;ORAL	300MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065264-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2006-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065264-001	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 2 · 41 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	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065264-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065264-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065264-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065264-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065264-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065264-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065264-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065264-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065264-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065264-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065264-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065264-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065264-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065264-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065264-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065264-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065264-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065264-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065264-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065264-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065264-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065264-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065264-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065264-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065264-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Preferred Pharmaceuticals, Inc.	8787ea15-bf90-4178-9b0f-08b075f1aa3d	2026-03-24	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264
Cefdinir	CEFDINIR	Lupin Pharmaceuticals, Inc.	cb7366ce-1778-451f-aba5-65cf73c9b87a	2025-10-14	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264 ndc (product): 68180-711
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	86c21cdd-8b94-f4dc-e053-2991aa0a51eb	2025-08-20	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264 ndc (product): 68071-4856
Cefdinir	CEFDINIR	A-S Medication Solutions	12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70	2025-04-01	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264 ndc (product): 50090-1033

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-1150	Cefdinir	Cefdinir	Atlantic Biologicals Corps	ANDA	Current
43063-466	Cefdinir	Cefdinir	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-1033	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-1033	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-1033	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-1034	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
55700-764	Cefdinir	Cefdinir	Quality Care Products, LLC	ANDA	Current
55700-764	Cefdinir	Cefdinir	Quality Care Products, LLC	ANDA	Current
55700-764	Cefdinir	Cefdinir	Quality Care Products, LLC	ANDA	Current
55700-764	Cefdinir	Cefdinir	Quality Care Products, LLC	ANDA	Current
57297-711	Cefdinir	Cefdinir	LUPIN LIMITED	ANDA	Current
67296-0469	Cefdinir	Cefdinir	RedPharm Drug Inc.	ANDA	Current
67296-0469	Cefdinir	Cefdinir	RedPharm Drug, Inc.	ANDA	Current
67296-0469	Cefdinir	Cefdinir	RedPharm Drug, Inc.	ANDA	Current
68001-150	Cefdinir	Cefdinir	BluePoint Laboratories	ANDA	Current
68071-4856	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4856	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-711	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-711	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-711	Cefdinir	Cefdinir	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-3577	Cefdinir	Cefdinir	REMEDYREPACK INC.	ANDA	Current
70934-343	Cefdinir	Cefdinir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-343	Cefdinir	Cefdinir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-343	Cefdinir	Cefdinir	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8393	ORIG	2006-05-22