Cefdinir

Product NDC: 87063-345
11-digit product format: 870630345
Labeler code: 87063
Product ID: 87063-345_5ce8c18e-a248-4f7f-e063-6394a90ae18e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: ASCLEMED USA INC.
Application: ANDA065368
Marketing category: ANDA
Marketing start: 2007-05-09
Substance: CEFDINIR
Active strength: 300 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A065368-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2007-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065368-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065368-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065368-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065368-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065368-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065368-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065368-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065368-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065368-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065368-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065368-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065368-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065368-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065368-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065368-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065368-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065368-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065368-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065368-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065368-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065368-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065368-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065368-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065368-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065368-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065368-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065368-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065368-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065368-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065368-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065368-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065368-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065368-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065368-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065368-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065368-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065368-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065368-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065368-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065368-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065368-001	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Cefdinir
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFDINIR	300 mg/1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	AvKARE	1acc5d17-10a4-e23d-e063-6394a90a52c3	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065368 application number: ANDA065368
Cefdinir	CEFDINIR	Teva Pharmaceuticals USA, Inc.	de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c	2018-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065368 application number: ANDA065368

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CI0FAO63WC	CEFDINIR	91832-40-5	CEFDINIR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87063-345-01	87063034501	100 CAPSULE in 1 BOTTLE (87063-345-01)	100 capsule	2026-10-03	No	No	Current
87063-345-30	87063034530	30 CAPSULE in 1 BOTTLE (87063-345-30)	30 capsule	2026-10-03	No	No	Current
87063-345-60	87063034560	60 CAPSULE in 1 BOTTLE (87063-345-60)	60 capsule	2026-10-03	No	No	Current
87063-345-90	87063034590	90 CAPSULE in 1 BOTTLE (87063-345-90)	90 capsule	2026-10-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFDINIR CAPSULES USP Rx only	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-10-03	HUMAN PRESCRIPTION DRUG LABEL	1