Cefadroxil

Product NDC: 80425-0198
Requested package NDC: 80425-0198-3
11-digit product format: 804250198
Labeler code: 80425
Product ID: 80425-0198_10f671c2-e1e0-da2f-e063-6394a90a8724
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefadroxil
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA065352
Marketing category: ANDA
Marketing start: 2022-11-02
Substance: CEFADROXIL
Active strength: 500 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
A065352-001	CEFADROXIL	CEFADROXIL/CEFADROXIL HEMIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB		2007-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065352-001	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	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065352-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-01-25	`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	A065352-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065352-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065352-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065352-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065352-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065352-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065352-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065352-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065352-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065352-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065352-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065352-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065352-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065352-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065352-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065352-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065352-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065352-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065352-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065352-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065352-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065352-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065352-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065352-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065352-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065352-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065352-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065352-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065352-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065352-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065352-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065352-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065352-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065352-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065352-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065352-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065352-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065352-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065352-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065352-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
ec836a53-7ed1-79b9-e053-2a95a90a9c36	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	SPL version
80425-0198-1	Cefadroxil	10 in 1 BOTTLE	CAPSULE	10	6
80425-0198-2	Cefadroxil	30 in 1 BOTTLE	CAPSULE	30	6
80425-0198-3	Cefadroxil	20 in 1 BOTTLE	CAPSULE	20	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0198-1	EA - Each	80425-0198	fa6bd022-72c2-49de-bfe1-dfbaf2458edb	1	2023-06-06
80425-0198-2	EA - Each	80425-0198	60265ca7-1c82-4fa4-9812-67a2a18e68ac	1	2023-06-06
80425-0198-3	EA - Each	80425-0198	88c9d8eb-6a94-4384-b6a3-712df2260789	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0198	CEFADROXIL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	6	Current NDC, Legacy NDC, 3 package rows	20240210_ec836a53-7ed1-79b9-e053-2a95a90a9c36.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefadroxil	CEFADROXIL	Redpharm Drug	4fb524c1-f985-2a8f-e063-6394a90aab7f	2026-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	Preferred Pharmaceuticals Inc.	41bc5f5a-5e1d-4cb6-a795-9f1756a8f074	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	RedPharm Drug, Inc.	97193a92-12ff-cfab-e053-2a95a90a9f14	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	PD-Rx Pharmaceuticals, Inc.	ab9cf28c-7c16-4bfa-879d-c360b4d1d5a6	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
CEFADROXIL	CEFADROXIL	DIRECT RX	a7e74b63-9d5c-7baa-e053-2a95a90a98b2	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	Direct_Rx	02566385-46f3-255a-e063-6294a90a1d1c	2024-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	a218d8d3-af90-4599-e053-2995a90a0ede	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	8bdd68a4-4e2e-0170-e053-2a95a90adb78	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	7278a39f-9de1-c9e2-e053-2a91aa0aea34	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	Advanced Rx Pharmacy of Tennessee, LLC	1a50b564-b00f-58e4-e063-6294a90af2c6	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	NuCare Pharmaceuticals,Inc.	16f3dd01-650a-2426-e063-6394a90a1b4b	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	Bryant Ranch Prepack	672519a7-11a1-4d8e-b2ca-dc9598c2f179	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	Bryant Ranch Prepack	9c3bed82-6df0-4643-944a-a826f7dc018f	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	Bryant Ranch Prepack	8cdaac56-b84a-4b6b-b94d-cab15d5961c5	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	A-S Medication Solutions	41ab333a-fafb-4647-844e-f3b2a76723cb	2024-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	Advanced Rx Pharmacy of Tennessee, LLC	ec836a53-7ed1-79b9-e053-2a95a90a9c36	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352 ndc (package): 80425-0198-3 ndc (product): 80425-0198 ndc11 (package): 80425019803
Cefadroxil	CEFADROXIL	Rising Pharma Holdings, Inc.	74c99fd8-16d1-4d2c-9158-42ff5eed2b7c	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	Aurobindo Pharma Limited	7bb90096-14d3-400e-94d3-048bff6b1292	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352
Cefadroxil	CEFADROXIL	NorthStar Rx LLC	17123057-58c7-401a-b87d-8c4c0764bbf6	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065352 application number: ANDA065352

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	ec836a53-7ed1-79b9-e053-2a95a90a9c36	6
309049	cefadroxil 500 MG Oral Capsule	SCD	ec836a53-7ed1-79b9-e053-2a95a90a9c36	6
309049	cefadroxil (as cefadroxil monohydrate) 500 MG Oral Capsule	SY	ec836a53-7ed1-79b9-e053-2a95a90a9c36	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0198-3	80425019803	20 CAPSULE in 1 BOTTLE (80425-0198-3)	20 capsule	2024-02-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefadroxil Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-02-09	HUMAN PRESCRIPTION DRUG LABEL	6