Amoxicillin and Clavulanate Potassium

Product NDC: 53808-0759
11-digit product format: 538080759
Labeler code: 53808
Product ID: 53808-0759_e30a8bdd-87ca-4886-a55e-d807763bd4c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA065189
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 250 mg/1; mg/1
Pharmacologic classes: beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
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	53808-0759		I	Inactivated by FDA		2026-08-03
excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA		2026-08-03

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	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	53808-0759		I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0759	53808-0759-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065189-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`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	A065189-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065189-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065189-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065189-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065189-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065189-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065189-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065189-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065189-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065189-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065189-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065189-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065189-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065189-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065189-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065189-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065189-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065189-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065189-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065189-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065189-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065189-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065189-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065189-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065189-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065189-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065189-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065189-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065189-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065189-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065189-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065189-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065189-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065189-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065189-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065189-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065189-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065189-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065189-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065189-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sandoz Inc	7cba82f0-9886-46e9-8dbd-43a448aade29	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065189 application number: ANDA065189
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	a94cfba3-27ed-46a3-81ef-e9b80187c207	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065189 application number: ANDA065189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0759-1	2019-10-21	C162847	48780-1	956f9ecf-c4b0-621f-e053-dbdaa90a74ad	Amoxicillin and Clavulanate Potassium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0759-1	Amoxicillin and Clavulanate Potassium	1 in 1 DOSE PACK	TABLET, FILM COATED	1		1
53808-0759-1	Amoxicillin and Clavulanate Potassium	30 in 1 CARTON	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0759	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 2 package rows	20100805_7f725b99-c327-4ba4-a3cb-356f344be778.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
Q42OMW3AT8	CLAVULANATE POTASSIUM	61177-45-5	CLAVULANATE POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	7f725b99-c327-4ba4-a3cb-356f344be778	1
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	7f725b99-c327-4ba4-a3cb-356f344be778	1
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	7f725b99-c327-4ba4-a3cb-356f344be778	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0759-1	53808075901	1 in 1 DOSE PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium Tablets, USP	State of Florida DOH Central Pharmacy	2010-06-04	HUMAN PRESCRIPTION DRUG LABEL	1