Application 065418

Type: ANDA
Sponsor: ORCHID HLTHCARE

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 43.

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
A065418-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2007-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065418-001	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 · 43 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	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065418-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-07-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A065418-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065418-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065418-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065418-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065418-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065418-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065418-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065418-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065418-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065418-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065418-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065418-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065418-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065418-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065418-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065418-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065418-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065418-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065418-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065418-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065418-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065418-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065418-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065418-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065418-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065418-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065418-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065418-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065418-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065418-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065418-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065418-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065418-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065418-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065418-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065418-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065418-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065418-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065418-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065418-001	AB	1	`f41ea6bd6efb…`

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 2 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	f4f62b64-5350-4b4e-b8f2-381f54a0cd10	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Lupin Pharmaceuticals, Inc.	cb7366ce-1778-451f-aba5-65cf73c9b87a	2025-10-14	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	463084e5-908d-4bbc-b542-10b98211e28e	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	3c2130f9-a0d8-4a4e-bcad-36379202b7bb	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Lupin Pharmaceuticals, Inc.	7490df67-56c0-4a1c-8533-2107f3e8aea5	2025-09-23	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	86c21cdd-8b94-f4dc-e053-2991aa0a51eb	2025-08-20	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Bryant Ranch Prepack	63aa0304-574f-4d37-9fb4-26ffb058fbec	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Bryant Ranch Prepack	d5fd32d8-66de-4a9f-9b83-88b190a90377	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	1d58b10c-b253-4925-8681-580aa2e8ae2e	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Ascend Laboratories, LLC	18888955-4db3-4d0d-939f-eaaa5f2e0dc4	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Asclemed USA, Inc.	e90660c8-2714-4592-aeaa-bc9ceb26057c	2025-04-19	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70	2025-04-01	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals, Inc.	2fb43fbe-2c4b-1df9-e063-6394a90a9913	2025-03-06	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	c5142dca-4fb8-467d-910a-e8228e694c94	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals, Inc.	4ade94bb-6c39-13cd-e054-00144ff8d46c	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	fbd76f8c-e6b8-52f4-e053-6394a90aa7ab	2025-02-04	Warnings	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Redpharm Drug, Inc.	f3d228c8-bde9-ffcf-e053-2a95a90aa5c4	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Cefdinir generic name: CEFDINIR
Cefdinir	CEFDINIR	Direct_Rx	f431ad55-24c8-e12a-e053-2a95a90aa043	2025-01-22	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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42043-250	Cefdinir	Cefdinir	OrchidPharma Inc	ANDA	Current
43063-597	Cefdinir	Cefdinir	PD-Rx Pharmaceuticals, In	ANDA	Current
63187-593	Cefdinir	Cefdinir	Proficient Rx LP	ANDA	Current
67296-1291	Cefdinir	Cefdinir	RedPharm Drug, Inc.	ANDA	Current
67296-1291	Cefdinir	Cefdinir	RedPharm Drug, Inc.	ANDA	Current
68071-3032	Cefdinir	Cefdinir	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3032	Cefdinir	Cefdinir	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9760	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9760	Cefdinir	Cefdinir	Preferred Pharmaceuticals Inc.	ANDA	Current