Cefdinir

Product NDC: 65862-177
11-digit product format: 658620177
Labeler code: 65862
Product ID: 65862-177_26399fd5-bcb0-4ab6-954a-ab3d5f20f2b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065434
Marketing category: ANDA
Marketing start: 2008-01-07
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	65862-177		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	65862-177	65862-177-15	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 40 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-177-15	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-177-15	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-177-15	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-177-15	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-177-15	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-177-15	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-177-15	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-177-15	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-177-15	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-177-15	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-177-15	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-177-15	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-177-15	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-177-15	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-177-15	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-177-15	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-177-15	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-177-15	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-177-15	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-177-15	`263afe128892…`	`91768de4ddbe…`

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
A065434-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2008-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065434-001	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 · 41 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	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065434-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2008-01-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065434-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065434-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065434-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065434-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065434-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065434-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065434-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065434-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065434-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065434-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065434-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065434-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065434-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065434-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065434-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065434-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065434-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065434-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065434-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065434-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065434-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065434-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065434-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065434-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065434-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065434-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065434-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065434-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065434-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065434-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065434-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065434-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065434-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065434-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065434-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065434-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065434-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065434-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065434-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065434-001	AB	1	`cb3db0bc1861…`

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
df26edb0-9bd6-449c-a187-0be0c9e2600c	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	SPL version
65862-177-05	Cefdinir	500 in 1 BOTTLE	CAPSULE	500	17
65862-177-30	Cefdinir	30 in 1 BOTTLE	CAPSULE	30	17
65862-177-60	Cefdinir	60 in 1 BOTTLE	CAPSULE	60	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-177-60	EA - Each	65862-177	a8ab38cc-9c67-4880-94a0-f59e18d844dc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-177	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	17	Current NDC, Legacy NDC, 3 package rows	20240213_df26edb0-9bd6-449c-a187-0be0c9e2600c.zip

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	NuCare Pharmaceuticals, Inc.	5128dc70-f3cd-25c0-e063-6294a90aa52f	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	c3892cd7-0e98-4ba3-a845-4aedf6c2a830	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	2da6eb80-63b0-4377-8d7b-865733ebbab1	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	a5f028d5-ab33-491e-a385-56e79e165150	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	REMEDYREPACK INC.	eb354221-c476-41cb-ad87-52423f81d698	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	9ba5cb2d-6272-27de-e053-2995a90a58c8	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	e296387e-eb20-4451-a184-f91748a4e9c7	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	f4f62b64-5350-4b4e-b8f2-381f54a0cd10	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	463084e5-908d-4bbc-b542-10b98211e28e	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	3c2130f9-a0d8-4a4e-bcad-36379202b7bb	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	Direct_Rx	f431ad55-24c8-e12a-e053-2a95a90aa043	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	54b06071-f3cb-5627-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	8c3b89a9-cb3f-5960-e053-2995a90aaeee	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	Rising Pharma Holdings, Inc.	a5594006-8e37-459e-8e85-7e2a83d7a57e	2024-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	Aurobindo Pharma Limited	df26edb0-9bd6-449c-a187-0be0c9e2600c	2024-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434 ndc (product): 65862-177
Cefdinir	CEFDINIR	A-S Medication Solutions	7c25ae35-61f4-4aef-a8d9-8de77b02ab80	2023-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	Proficient Rx LP	506bcf51-3b7e-4fc0-b22e-a5b726471e3a	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434
Cefdinir	CEFDINIR	BluePoint Laboratories	e342b7cf-f527-476e-8119-b1fd81c58b55	2023-03-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065434 application number: ANDA065434

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	f4f62b64-5350-4b4e-b8f2-381f54a0cd10	24
200346	cefdinir 300 MG Oral Capsule	PSN	e296387e-eb20-4451-a184-f91748a4e9c7	24
200346	cefdinir 300 MG Oral Capsule	SCD	f4f62b64-5350-4b4e-b8f2-381f54a0cd10	24
200346	cefdinir 300 MG Oral Capsule	SCD	e296387e-eb20-4451-a184-f91748a4e9c7	24
200346	cefdinir 300 MG Oral Capsule	PSN	a5f028d5-ab33-491e-a385-56e79e165150	18
200346	cefdinir 300 MG Oral Capsule	SCD	a5f028d5-ab33-491e-a385-56e79e165150	18
200346	cefdinir 300 MG Oral Capsule	PSN	df26edb0-9bd6-449c-a187-0be0c9e2600c	17
200346	cefdinir 300 MG Oral Capsule	SCD	df26edb0-9bd6-449c-a187-0be0c9e2600c	17
200346	cefdinir 300 MG Oral Capsule	PSN	9a90c686-fea0-47bb-bd71-e200b0e19c35	10
200346	cefdinir 300 MG Oral Capsule	SCD	9a90c686-fea0-47bb-bd71-e200b0e19c35	10
200346	cefdinir 300 MG Oral Capsule	PSN	9ba5cb2d-6272-27de-e053-2995a90a58c8	5
200346	cefdinir 300 MG Oral Capsule	SCD	9ba5cb2d-6272-27de-e053-2995a90a58c8	5
200346	cefdinir 300 MG Oral Capsule	PSN	2da6eb80-63b0-4377-8d7b-865733ebbab1	4
200346	cefdinir 300 MG Oral Capsule	SCD	2da6eb80-63b0-4377-8d7b-865733ebbab1	4
200346	cefdinir 300 MG Oral Capsule	PSN	f431ad55-24c8-e12a-e053-2a95a90aa043	3
200346	cefdinir 300 MG Oral Capsule	PSN	1a8e02a1-ecd0-41c5-8917-164991d9ceca	3
200346	cefdinir 300 MG Oral Capsule	PSN	a78a68a4-5425-43c4-81cc-7733b72445b8	3
200346	cefdinir 300 MG Oral Capsule	SCD	f431ad55-24c8-e12a-e053-2a95a90aa043	3
200346	cefdinir 300 MG Oral Capsule	SCD	1a8e02a1-ecd0-41c5-8917-164991d9ceca	3
200346	cefdinir 300 MG Oral Capsule	SCD	a78a68a4-5425-43c4-81cc-7733b72445b8	3
200346	cefdinir 300 MG Oral Capsule	PSN	a3262279-1f9e-401b-9b02-6da3ef374b46	1
200346	cefdinir 300 MG Oral Capsule	PSN	a84712bf-221d-4366-9cf0-b8c19428c276	1
200346	cefdinir 300 MG Oral Capsule	PSN	1181a59e-a433-20d0-e054-00144ff88e88	1
200346	cefdinir 300 MG Oral Capsule	PSN	5128dc70-f3cd-25c0-e063-6294a90aa52f	1
200346	cefdinir 300 MG Oral Capsule	PSN	1c422c29-9200-2d09-e063-6394a90aeb1a	1
200346	cefdinir 300 MG Oral Capsule	SCD	a84712bf-221d-4366-9cf0-b8c19428c276	1
200346	cefdinir 300 MG Oral Capsule	SCD	a3262279-1f9e-401b-9b02-6da3ef374b46	1
200346	cefdinir 300 MG Oral Capsule	SCD	5128dc70-f3cd-25c0-e063-6294a90aa52f	1
200346	cefdinir 300 MG Oral Capsule	SCD	1c422c29-9200-2d09-e063-6394a90aeb1a	1
200346	cefdinir 300 MG Oral Capsule	SCD	1181a59e-a433-20d0-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-177-05	65862017705	500 CAPSULE in 1 BOTTLE (65862-177-05)	500 capsule	2008-01-07	0000-00-00	No	No	Current
65862-177-15	65862017715	1500 CAPSULE in 1 BAG (65862-177-15)	1500 capsule	07-JAN-08				Current
65862-177-30	65862017730	30 CAPSULE in 1 BOTTLE (65862-177-30)	30 capsule	2008-01-07	0000-00-00	No	No	Current
65862-177-60	65862017760	60 CAPSULE in 1 BOTTLE (65862-177-60)	60 capsule	2008-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir Capsules, USP Rx only	NuCare Pharmaceuticals, Inc.	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir Capsules, USP Rx only	Preferred Pharmaceuticals Inc.	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	4
Cefdinir Capsules, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	18
Cefdinir Capsules, USP Rx only	NuCare Pharmaceuticals,Inc.	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	5
Cefdinir Capsules, USP Rx only	REMEDYREPACK INC.	2025-11-21	HUMAN PRESCRIPTION DRUG LABEL	12
Cefdinir Capsules, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	24
Cefdinir Capsules, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	24
Cefdinir	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir Capsules, USP Rx only	Redpharm Drug	2024-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir Capsules, USP Rx only	Aurobindo Pharma Limited	2024-02-12	Human Prescription Drug Label	17
Cefdinir Capsules, USP Rx only	Preferred Pharmaceuticals Inc.	2021-04-05	HUMAN PRESCRIPTION DRUG LABEL	2
Cefdinir Capsules, USP Rx only	A-S Medication Solutions	2021-02-22	Human Prescription Drug Label	10
Cefdinir Capsules, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir Capsules, USP Rx Only	Blenheim Pharmacal, Inc.	2015-03-17	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir Capsules	H.J. Harkins Company, Inc. \| Aurobindo Pharma Limited	2011-08-23	Human Prescription Drug Label	1
Cefdinir Capsules	Rebel Distributors Corp	2011-01-17	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir Capsules	Physicians Total Care, Inc.	2010-12-02	Human Prescription Drug Label	3