Cefdinir

Product NDC: 72189-423
11-digit product format: 721890423
Labeler code: 72189
Product ID: 72189-423_2c4d38b9-5b23-a07e-e063-6294a90ae9c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA065434
Marketing category: ANDA
Marketing start: 2023-02-08
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

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 · 6 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
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-423-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-423-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-423-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-423-20	`0efc9e666f02…`	`f202fb6c5f17…`

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
f431ad55-24c8-e12a-e053-2a95a90aa043	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
72189-423-14	Cefdinir	14 in 1 BOTTLE	CAPSULE	14		3
72189-423-20	Cefdinir	20 in 1 BOTTLE	CAPSULE	20		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-423-14	EA - Each	72189-423	d4f5a38d-e1d4-47c8-b78d-8795670e1db7	1	2023-07-06
72189-423-20	EA - Each	72189-423	f4073b5e-d3ed-483e-8e0c-120ce171553d	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-423	CEFDINIR CAPSULE [DIRECT_RX]	3	Current NDC, 2 package rows	20250123_f431ad55-24c8-e12a-e053-2a95a90aa043.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 ndc (product): 72189-423
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
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	f431ad55-24c8-e12a-e053-2a95a90aa043	3
200346	cefdinir 300 MG Oral Capsule	SCD	f431ad55-24c8-e12a-e053-2a95a90aa043	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-423-14	72189042314	14 CAPSULE in 1 BOTTLE (72189-423-14)	14 capsule	2023-02-08	No	No	Current
72189-423-20	72189042320	20 CAPSULE in 1 BOTTLE (72189-423-20)	20 capsule	2023-02-08	No	No	Current