CEFDINIR

Product NDC: 72189-308
11-digit product format: 721890308
Labeler code: 72189
Product ID: 72189-308_2c3cf3d6-130e-5a5b-e063-6394a90aeefa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFDINIR
Dosage form: CAPSULE
Route: ORAL
Labeler: DirectRx
Application: ANDA210220
Marketing category: ANDA
Marketing start: 2022-02-02
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#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 6 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	72189-308		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-308	72189-308-14	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-308	72189-308-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	72189-308		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-308	72189-308-14	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-308	72189-308-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`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
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (product): 72189-308
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

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
d70b9e1f-908f-b570-e053-2995a90af098	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
72189-308-14	CEFDINIR	14 in 1 BOTTLE	CAPSULE	14		3
72189-308-20	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
72189-308-14	EA - Each	72189-308	50e0d4e0-06a8-407e-8ff6-f0b852f8478f	1	2022-09-12
72189-308-20	EA - Each	72189-308	f60ff8dc-a4d4-46c3-8f23-89261e8fd2d6	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-308	CEFDINIR CAPSULE [DIRECTRX]	3	Current NDC, Legacy NDC, 2 package rows	20250122_d70b9e1f-908f-b570-e053-2995a90af098.zip

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	d70b9e1f-908f-b570-e053-2995a90af098	3
200346	cefdinir 300 MG Oral Capsule	SCD	d70b9e1f-908f-b570-e053-2995a90af098	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-308-14	72189030814	14 CAPSULE in 1 BOTTLE (72189-308-14)	14 capsule	2022-02-02	0000-00-00	No	No	Current
72189-308-20	72189030820	20 CAPSULE in 1 BOTTLE (72189-308-20)	20 capsule	2022-02-02	0000-00-00	No	No	Current