Amoxicillin and Clavulanate Potassium

Product NDC: 43598-220
11-digit product format: 435980220
Labeler code: 43598
Product ID: 43598-220_281d6c99-708d-bd90-e14e-dd9e6749db4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin and clavulanate potassium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc
Application: NDA050785
Marketing category: NDA
Marketing start: 2003-09-11
Marketing end: 0000-00-00
Substance: AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM
Active strength: 563 mg/1; mg/1; mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS],Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43598-220		I	Inactivated by FDA	2026-10-05
excluded package	package	43598-220	43598-220-28	I	Inactivated by FDA	2026-10-05
excluded package	package	43598-220	43598-220-40	I	Inactivated by FDA	2026-10-05

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43598-220-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43598-220-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43598-220-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43598-220-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43598-220-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43598-220-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43598-220-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43598-220-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43598-220-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43598-220-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43598-220-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43598-220-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43598-220-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43598-220-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43598-220-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43598-220-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43598-220-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43598-220-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43598-220-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43598-220-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43598-220-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43598-220-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43598-220-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43598-220-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43598-220-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43598-220-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43598-220-28	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43598-220-40	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43598-220-28	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43598-220-40	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43598-220-28	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43598-220-40	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43598-220-28	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43598-220-40	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43598-220-28	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43598-220-40	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43598-220-28	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43598-220-40	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43598-220-28	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43598-220-40	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050785-001	AUGMENTIN XR	AMOXICILLIN; CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050785-001	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 · 43 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
2026-09-14 22:38:34	2026-08	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2002-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2002-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2002-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2002-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050785-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050785-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050785-001	AB	1	`011fe1cb6892…`
2019-12-13 00:20 UTC	2019-12	N050785-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N050785-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050785-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050785-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050785-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050785-001	6746692	2020-04-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	6783773	2020-04-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	6878386	2020-04-04	U-926		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	7250176	2020-04-04	U-926		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6746692	2020-04-04		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6783773	2020-04-04		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6878386	2020-04-04	U-926		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	7250176	2020-04-04	U-926		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6746692	2020-04-04		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6783773	2020-04-04		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6878386	2020-04-04	U-926		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	7217430	2020-04-04	U-926	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	7250176	2020-04-04	U-926		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6746692	2020-04-04		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6783773	2020-04-04		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6878386	2020-04-04	U-926		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	7250176	2020-04-04	U-926		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6746692	2020-04-04		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6783773	2020-04-04		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6878386	2020-04-04	U-926		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	7217430	2020-04-04	U-926	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	7250176	2020-04-04	U-926		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6746692	2020-04-04		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6783773	2020-04-04		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6878386	2020-04-04	U-926		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	7217430	2020-04-04	U-926	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	7250176	2020-04-04	U-926		`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
43598-220-28	2020-01-31	C162847	48780-1	9d75b9cf-e216-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Extended Release Tablets safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Extended Release Tablets Amoxicillin and Clavulanate Potassium Extended Release Tablets for oral use. Initial U.S. Approval: 2002 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and
43598-220-40	2020-01-31	C162847	48780-1	9d75b9cf-e216-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Extended Release Tablets safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Extended Release Tablets Amoxicillin and Clavulanate Potassium Extended Release Tablets for oral use. Initial U.S. Approval: 2002 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-220-28	Amoxicillin and Clavulanate Potassium Extended Release	28 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	28		6
43598-220-40	Amoxicillin and Clavulanate Potassium Extended Release	40 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	40		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-220-28	EA - Each	43598-220	3d5be574-acff-4e3a-8e9f-24c8defd9e52	1	2012-07-24
43598-220-40	EA - Each	43598-220	ebc18559-da18-46d2-90d1-f8a770c0ecf6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
AMOXICILLIN SODIUM	ACTIVE INGREDIENT	544Y3D6MYH	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-220	AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	6	Legacy NDC, 2 package rows	20141014_fc4bb4b0-9330-4701-a600-199c42fb3255.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 · 1 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	USAntibiotics, LLC	45c60b69-1b65-01ed-e063-6294a90a57be	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050785 application number: NDA050785

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
544Y3D6MYH	AMOXICILLIN SODIUM	34642-77-8	AMOXICILLIN SODIUM
Q42OMW3AT8	CLAVULANATE POTASSIUM	61177-45-5	CLAVULANATE POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617995	amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral Tablet	PSN	fc4bb4b0-9330-4701-a600-199c42fb3255	6
617995	12 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral Tablet	SCD	fc4bb4b0-9330-4701-a600-199c42fb3255	6
617995	amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral Tablet	SY	fc4bb4b0-9330-4701-a600-199c42fb3255	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43598-220-28	43598022028	28 in 1 BOTTLE	Historical
43598-220-40	43598022040	40 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium Extended Release	Dr. Reddy's Laboratories Inc \| Dr. Reddy's Laboratories Inc. DBA Dr. Reddy's Laboratories Tennessee LLC \| Dr. Reddy's laboratories DBA Dr. Reddy's Laboratories Tennessee LLC \| Beecham Pharmaceuticals (PTE) Limited \| SmithKline Beecham Limited	2014-01-17	HUMAN PRESCRIPTION DRUG LABEL	6