Application 065429

Type: ANDA
Sponsor: ORCHID HLTHCARE

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 43.

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
A065429-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-07-18
A065429-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065429-001	AB
A065429-002	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 · 86 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	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A065429-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065429-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065429-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065429-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065429-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065429-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065429-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065429-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065429-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065429-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065429-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065429-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065429-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065429-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065429-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065429-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065429-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065429-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065429-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065429-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065429-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065429-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065429-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065429-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065429-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065429-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065429-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065429-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065429-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065429-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065429-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065429-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065429-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065429-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065429-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065429-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065429-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065429-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065429-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065429-002	AB	1	`74a2ff9319b5…`

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 3 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFDINIR	CEFDINIR	DIRECT RX	982d0f53-20bc-1cb4-e053-2995a90ad33c	2025-01-22	Warnings	Name fallback brand name: CEFDINIR generic name: CEFDINIR
CEFDINIR	CEFDINIR	DirectRx	d70b9e1f-908f-b570-e053-2995a90af098	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: CEFDINIR generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	c974d975-8616-3551-e053-2995a90a65f3	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	54b06071-f3cb-5627-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	1bbd75ea-5a50-eb00-e063-6394a90a1cec	2024-06-25	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	96cad498-70d3-3089-e053-2995a90a9d19	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	8c3b89a9-cb3f-5960-e053-2995a90aaeee	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	8dfbad95-4dd8-01fd-e053-2a95a90a1de1	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	American Health Packaging	c493e78b-afa3-4f74-8305-75e5f3817df0	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	beeb9480-f9f9-44ae-93f3-6f4da81888f5	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Aurobindo Pharma Limited	06fbdb63-d32f-4212-9962-f1de15597dda	2024-02-14	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Rising Pharma Holdings, Inc.	a5594006-8e37-459e-8e85-7e2a83d7a57e	2024-02-12	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Aurobindo Pharma Limited	df26edb0-9bd6-449c-a187-0be0c9e2600c	2024-02-12	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	10bf69e7-5f7e-4448-9f22-777f137d9666	2023-12-25	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
cefdinir	CEFDINIR	A-S Medication Solutions	7bbcc4ac-c964-4c6b-88c0-11c0ba9933db	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	a217d454-4ca0-4b29-8a64-eb9393a85269	2023-11-21	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	37b5d000-db9e-4b6e-8208-6361e98fb55d	2023-11-01	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	7c25ae35-61f4-4aef-a8d9-8de77b02ab80	2023-09-12	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Proficient Rx LP	506bcf51-3b7e-4fc0-b22e-a5b726471e3a	2023-07-01	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	fb02aaab-d2a0-466e-8327-72e3df1e4e9d	2023-04-04	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42043-251	Cefdinir	Cefdinir	OrchidPharma Inc	ANDA	Current
42043-252	Cefdinir	Cefdinir	OrchidPharma Inc	ANDA	Current
68071-3393	Cefdinir	Cefdinir	NuCare Pharmaceauticals,Inc.	ANDA	Current
68071-4236	Cefdinir	Cefdinir	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6840	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6840	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current