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 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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065429-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065429-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-07-18	`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	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…`
2022-03-09 01:35 UTC	2022-03	A065429-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065429-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065429-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065429-002	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 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Northwind Health Company, LLC	1d0d50ba-8c2b-855c-e063-6394a90a5c7d	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Proficient Rx LP	63d2f931-6896-47e5-905e-4f812d6cb105	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	REMEDYREPACK INC.	a8029f7c-6353-46db-8c8c-c86a9485a14f	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals, Inc.	5128dc70-f3cd-25c0-e063-6294a90aa52f	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	3714d558-cbaa-42e8-831b-ffbbc951ebf2	2026-04-21	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	5b6c1b5d-a1d5-4e08-9077-2af3f38fea4e	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	c3892cd7-0e98-4ba3-a845-4aedf6c2a830	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	2da6eb80-63b0-4377-8d7b-865733ebbab1	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	0d1212c9-604f-4999-8f7d-e7cf300705ef	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	2e384d98-642e-4841-9f62-fcea4c242f4e	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals, Inc.	8787ea15-bf90-4178-9b0f-08b075f1aa3d	2026-03-24	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	c23af6af-a97b-b98d-e053-2995a90ae780	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
cefdinir	CEFDINIR	A-S Medication Solutions	2bd2101c-511d-45a9-b1d8-a45ed40c5b80	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	a5f028d5-ab33-491e-a385-56e79e165150	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	REMEDYREPACK INC.	eb354221-c476-41cb-ad87-52423f81d698	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	AvKARE	1acc5d17-10a4-e23d-e063-6394a90a52c3	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	17b4e82f-4169-4ab9-bd4a-79781a71e160	2025-12-19	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	9ba5cb2d-6272-27de-e053-2995a90a58c8	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Major Pharmaceuticals	a0934baf-4745-4546-a63a-d4a660a188b3	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	e296387e-eb20-4451-a184-f91748a4e9c7	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR

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