Cefadroxil

Product NDC: 68788-8261
11-digit product format: 687888261
Labeler code: 68788
Product ID: 68788-8261_04451ec6-409d-40b1-b4a0-da3ca6bae328
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefadroxil
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA065392
Marketing category: ANDA
Marketing start: 2022-09-19
Substance: CEFADROXIL
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	68788-8261		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	68788-8261	68788-8261-3	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	68788-8261	68788-8261-2	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
A065392-001	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB		2007-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065392-001	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	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`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	A065392-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065392-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065392-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065392-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065392-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065392-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065392-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065392-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065392-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065392-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065392-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065392-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065392-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065392-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065392-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065392-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065392-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065392-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065392-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065392-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065392-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065392-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065392-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065392-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065392-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065392-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065392-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065392-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065392-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065392-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065392-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065392-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065392-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065392-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065392-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065392-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065392-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065392-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065392-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065392-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFADROXIL	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
280111G160	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309049	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
485bc35b-637a-426b-aaa2-023c664914ae	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
560bed03-0257-a1db-0638-2c46fc35054c	Product name	2	20170824
34f1b9ee-0673-df8c-ddae-36eaf4c48382	Product name	1	20140508
3793572a-4958-68b2-f923-8cf695ec1cc1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8261-2	Cefadroxil	50 in 1 BOTTLE	CAPSULE	50		4
68788-8261-3	Cefadroxil	30 in 1 BOTTLE	CAPSULE	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8261-2	EA - Each	68788-8261	5480c265-efdb-48e6-8f98-eacbf99e1396	1	2022-10-06
68788-8261-3	EA - Each	68788-8261	fe8e4d27-50bc-4ce2-b51d-f72eb2400e33	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8261	CEFADROXIL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250112_485bc35b-637a-426b-aaa2-023c664914ae.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefadroxil	CEFADROXIL	Proficient Rx LP	57eebea5-28b6-44a3-888b-76950f6038f4	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392
Cefadroxil	CEFADROXIL	REMEDYREPACK INC.	eb365f05-1c8f-4495-b443-abb0580b39fb	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392
Cefadroxil	CEFADROXIL	Preferred Pharmaceuticals, Inc.	485bc35b-637a-426b-aaa2-023c664914ae	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392 ndc (product): 68788-8261
Cefadroxil	CEFADROXIL	Redpharm Drug	1c50c0db-ca03-6217-e063-6294a90a89fa	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	7e931c7e-5ab6-c39c-e053-2a91aa0a59d9	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392
Cefadroxil	CEFADROXIL	Lupin Pharmaceuticals, Inc.	5fe066ce-2f97-49d7-81bd-a672be1ebecd	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392
Cefadroxil	CEFADROXIL	Bryant Ranch Prepack	caee9515-9a10-4020-af47-e9833aa69ef8	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392
Cefadroxil	CEFADROXIL	PD-Rx Pharmaceuticals, Inc.	f5bbbf87-f059-4bbd-aea9-27d31462654f	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392
Cefadroxil	CEFADROXIL	Direct_Rx	f6ddd84a-4a44-7035-e053-6294a90a6606	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392
Cefadroxil	CEFADROXIL	Advanced Rx of Tennessee, LLC	205cb17b-6fbf-e147-e063-6294a90a608e	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065392 application number: ANDA065392

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
280111G160	CEFADROXIL	66592-87-8	CEFADROXIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309049	cefadroxil 500 MG Oral Capsule	PSN	485bc35b-637a-426b-aaa2-023c664914ae	4
309049	cefadroxil 500 MG Oral Capsule	SCD	485bc35b-637a-426b-aaa2-023c664914ae	4
309049	cefadroxil (as cefadroxil monohydrate) 500 MG Oral Capsule	SY	485bc35b-637a-426b-aaa2-023c664914ae	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8261-2	68788826102	50 CAPSULE in 1 BOTTLE (68788-8261-2)	50 capsule	2022-09-19	0000-00-00	No	No	Current
68788-8261-3	68788826103	30 CAPSULE in 1 BOTTLE (68788-8261-3)	30 capsule	2022-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefadroxil Capsules USP 500 mg	Preferred Pharmaceuticals, Inc.	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	4