Cefadroxil

Product NDC: 10544-135
11-digit product format: 105440135
Labeler code: 10544
Product ID: 10544-135_11e2a86f-0d12-4eda-8472-9b94efe2ef58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefadroxil
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA065392
Marketing category: ANDA
Marketing start: 2011-07-11
Marketing end: 0000-00-00
Substance: CEFADROXIL
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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
excluded product	product	10544-135		I	Inactivated by FDA		2026-08-17
excluded package	package	10544-135	10544-135-20	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-135-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-135-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-135-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-135-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-135-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-135-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-135-20	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-135-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-135-20	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-135-20	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-135-20	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-135-20	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-135-20	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-135-20	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-135-20	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-135-20	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-135-20	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-135-20	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-135-20	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-135-20	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10544-135-20	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10544-135-20	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 06:07:40	2026-07	A065392-001	CEFADROXIL	EQ 500MG BASE	CAPSULE / ORAL	AB	2007-05-29	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065392-001	AB	1	`caaa826d4ba7…`
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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-135-20	2020-01-31	C162847	48780-1	9d75b9d0-5365-f424-e053-dadaa90a57ce	Cefadroxil Capsules USP 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-135-20	Cefadroxil	50 in 1 BOTTLE	CAPSULE	50		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-135-20	EA - Each	10544-135	2b820c13-11ab-49a3-bcdf-0752aaad783b	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFADROXIL	ACTIVE INGREDIENT	280111G160	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CEFADROXIL ANHYDROUS	ACTIVE MOIETY	Q525PA8JJB	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-135	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2	Legacy NDC, 1 package rows	20151111_615617a6-40b9-46e2-9a3d-169ea5a671de.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
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	615617a6-40b9-46e2-9a3d-169ea5a671de	2
309049	cefadroxil 500 MG Oral Capsule	SCD	615617a6-40b9-46e2-9a3d-169ea5a671de	2
309049	cefadroxil (as cefadroxil monohydrate) 500 MG Oral Capsule	SY	615617a6-40b9-46e2-9a3d-169ea5a671de	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-135-20	10544013520	50 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefadroxil Capsules USP 500 mg	Blenheim Pharmacal, Inc.	2015-11-10	HUMAN PRESCRIPTION DRUG LABEL	2