Cefdinir

Product NDC: 0904-7563
11-digit product format: 009047563
Labeler code: 0904
Product ID: 0904-7563_a0934baf-4745-4546-a63a-d4a660a188b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA210220
Marketing category: ANDA
Marketing start: 2025-10-27
Substance: CEFDINIR
Active strength: 300 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210220-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2021-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210220-001	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.

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	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210220-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2021-02-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210220-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210220-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210220-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210220-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210220-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210220-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210220-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210220-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210220-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210220-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210220-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210220-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210220-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210220-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210220-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210220-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210220-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210220-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210220-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210220-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210220-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210220-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210220-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210220-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210220-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210220-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210220-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210220-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210220-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210220-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210220-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210220-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210220-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210220-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cefdinir
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFDINIR	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CI0FAO63WC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200346	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a0934baf-4745-4546-a63a-d4a660a188b3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d3e72f63-2c41-955f-f4ce-e90c6403e67c	Product name	2	20210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1	Product name	2	20210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7563-04	Cefdinir	10 in 1 BLISTER PACK	CAPSULE	10		1
0904-7563-04	Cefdinir	3 in 1 CARTON	CAPSULE	3		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7563-04	EA - Each	0904-7563	5538ccb6-0489-4038-870c-437a7723612b	1	2025-11-13

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 · 15 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	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Proficient Rx LP	63d2f931-6896-47e5-905e-4f812d6cb105	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	REMEDYREPACK INC.	a8029f7c-6353-46db-8c8c-c86a9485a14f	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	c23af6af-a97b-b98d-e053-2995a90ae780	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Major Pharmaceuticals	a0934baf-4745-4546-a63a-d4a660a188b3	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220 ndc (product): 0904-7563
Cefdinir	CEFDINIR	Bryant Ranch Prepack	63aa0304-574f-4d37-9fb4-26ffb058fbec	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Bryant Ranch Prepack	d5fd32d8-66de-4a9f-9b83-88b190a90377	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Ascend Laboratories, LLC	18888955-4db3-4d0d-939f-eaaa5f2e0dc4	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	c5142dca-4fb8-467d-910a-e8228e694c94	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	Redpharm Drug, Inc.	f3d228c8-bde9-ffcf-e053-2a95a90aa5c4	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
CEFDINIR	CEFDINIR	DirectRx	d70b9e1f-908f-b570-e053-2995a90af098	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	c974d975-8616-3551-e053-2995a90a65f3	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	American Health Packaging	c493e78b-afa3-4f74-8305-75e5f3817df0	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	A-S Medication Solutions	10bf69e7-5f7e-4448-9f22-777f137d9666	2023-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220
Cefdinir	CEFDINIR	A-S Medication Solutions	a217d454-4ca0-4b29-8a64-eb9393a85269	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210220 application number: ANDA210220

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200346	cefdinir 300 MG Oral Capsule	PSN	a0934baf-4745-4546-a63a-d4a660a188b3	1
200346	cefdinir 300 MG Oral Capsule	SCD	a0934baf-4745-4546-a63a-d4a660a188b3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7563-04	00904756304	3 BLISTER PACK in 1 CARTON (0904-7563-04) / 10 CAPSULE in 1 BLISTER PACK	3 blister pack	2025-10-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir	Major Pharmaceuticals \| Alkem Laboratories Limited	2025-10-23	Human Prescription Drug Label	1