Application 065473

Type: ANDA
Sponsor: AUROBINDO PHARMA

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
A065473-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14
A065473-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065473-001	AB
A065473-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`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	A065473-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065473-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065473-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065473-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065473-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065473-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065473-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065473-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065473-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065473-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065473-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065473-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065473-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065473-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065473-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065473-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065473-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065473-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065473-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065473-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065473-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065473-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065473-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065473-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065473-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065473-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065473-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065473-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065473-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065473-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065473-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065473-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065473-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065473-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065473-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065473-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065473-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065473-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065473-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065473-002	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	5b6c1b5d-a1d5-4e08-9077-2af3f38fea4e	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 68788-7844
CEFDINIR	CEFDINIR	DIRECT RX	982d0f53-20bc-1cb4-e053-2995a90ad33c	2025-01-22	Warnings	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 72189-185 ndc (product): 72189-186
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	96cad498-70d3-3089-e053-2995a90a9d19	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 68071-5106
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	8dfbad95-4dd8-01fd-e053-2a95a90a1de1	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 68071-4970
Cefdinir	CEFDINIR	A-S Medication Solutions	beeb9480-f9f9-44ae-93f3-6f4da81888f5	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 50090-2735
Cefdinir	CEFDINIR	Aurobindo Pharma Limited	06fbdb63-d32f-4212-9962-f1de15597dda	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 65862-218 ndc (product): 65862-219
Cefdinir	CEFDINIR	A-S Medication Solutions	fb02aaab-d2a0-466e-8327-72e3df1e4e9d	2023-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473
Cefdinir	CEFDINIR	Proficient Rx LP	be963e80-e298-49a0-a52f-3d4dcded7c8c	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 63187-835
Cefdinir	CEFDINIR	Proficient Rx LP	8305b5d8-53b3-475a-b263-07d5fd81392a	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 71205-405

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-392	Cefdinir	Cefdinir	NorthStar Rx LLC	ANDA	Current
16714-392	Cefdinir	Cefdinir	NorthStar Rx LLC	ANDA	Current
16714-392	Cefdinir	Cefdinir	NorthStar Rx LLC	ANDA	Current
16714-393	Cefdinir	Cefdinir	NorthStar Rx LLC	ANDA	Current
16714-393	Cefdinir	Cefdinir	NorthStar Rx LLC	ANDA	Current
16714-393	Cefdinir	Cefdinir	NorthStar Rx LLC	ANDA	Current
21695-622	Cefdinir	Cefdinir	Rebel Distributors Corp	ANDA	Current
50090-1027	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-2735	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-2735	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
50090-5583	Cefdinir	Cefdinir	A-S Medication Solutions	ANDA	Current
53217-298	Cefdinir	Cefdinir	Aidarex Pharmaceuticals LLC	ANDA	Current
63187-835	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
63187-835	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
63187-835	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
63187-835	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
65862-218	Cefdinir	Cefdinir	Aurobindo Pharma Limited	ANDA	Current
65862-218	Cefdinir	Cefdinir	Aurobindo Pharma Limited	ANDA	Current
65862-218	Cefdinir	Cefdinir	Aurobindo Pharma Limited	ANDA	Current
65862-219	Cefdinir	Cefdinir	Aurobindo Pharma Limited	ANDA	Current
65862-219	Cefdinir	Cefdinir	Aurobindo Pharma Limited	ANDA	Current
65862-219	Cefdinir	Cefdinir	Aurobindo Pharma Limited	ANDA	Current
68071-1645	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2599	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4419	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4419	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4792	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4792	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4970	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4970	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5106	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5106	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7478	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7478	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7478	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7844	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7844	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-405	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
71205-405	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
71205-405	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
72189-185	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-185	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-185	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-186	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-186	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current
72189-186	CEFDINIR	CEFDINIR	DIRECT RX	ANDA	Current