amoxicillin and clavulanate potassium

Product NDC: 43598-221
11-digit product format: 435980221
Labeler code: 43598
Product ID: 43598-221_4291f971-d386-411e-8d06-95be682a3961
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin and clavulanate potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc
Application: NDA050720
Marketing category: NDA
Marketing start: 1996-10-02
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 875 mg/1; mg/1
Pharmacologic classes: 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	43598-221		I	Inactivated by FDA	2026-10-05
excluded package	package	43598-221	43598-221-14	I	Inactivated by FDA	2026-10-05
excluded package	package	43598-221	43598-221-78	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	43598-221-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43598-221-14	`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	43598-221-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43598-221-14	`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	43598-221-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43598-221-14	`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	43598-221-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43598-221-14	`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	43598-221-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43598-221-14	`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	43598-221-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43598-221-14	`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	43598-221-78	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43598-221-14	`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	43598-221-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43598-221-14	`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	43598-221-78	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43598-221-14	`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	43598-221-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43598-221-14	`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	43598-221-78	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43598-221-14	`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	43598-221-78	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43598-221-14	`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	43598-221-78	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43598-221-14	`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	43598-221-78	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43598-221-14	`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	43598-221-78	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43598-221-14	`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	43598-221-78	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43598-221-14	`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	43598-221-78	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43598-221-14	`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	43598-221-78	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43598-221-14	`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	43598-221-78	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43598-221-14	`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	43598-221-78	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43598-221-14	`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
N050720-001	AUGMENTIN '875'	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050720-001	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	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050720-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050720-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050720-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050720-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050720-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050720-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050720-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050720-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050720-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050720-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050720-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050720-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050720-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050720-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050720-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050720-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050720-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050720-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050720-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050720-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050720-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050720-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050720-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050720-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050720-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050720-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050720-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050720-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050720-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050720-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050720-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050720-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050720-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050720-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050720-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050720-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050720-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050720-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050720-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050720-001	AB	1	`f41ea6bd6efb…`

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
43598-221-14	2020-01-31	C162847	48780-1	9d75b9d0-4c36-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium. A moxicillin and Clavulanate Potassium Tablets, Powder for Oral Suspension and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate
43598-221-78	2020-01-31	C162847	48780-1	9d75b9d0-4c36-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium. A moxicillin and Clavulanate Potassium Tablets, Powder for Oral Suspension and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-221-14	amoxicillin and clavulanate potassium	20 in 1 BOTTLE	TABLET, FILM COATED	20		7
43598-221-78	amoxicillin and clavulanate potassium	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-221-14	EA - Each	43598-221	e3684ddd-dda4-48b2-b581-578ab45edb6a	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 TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	6
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-221	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]	7	Legacy NDC, 2 package rows	20160913_58a20183-4eb6-438e-bd1e-a74f4645bb0d.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 · 3 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	Preferred Pharmaceuticals Inc.	1b8a6312-ae47-45fb-ba5e-eedbc176afa0	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	00cf4429-e37c-4490-b22d-3cd796124296	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	0d40bc70-8f47-48c2-a7c6-ba7db9cace74	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720

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
617423	amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral Suspension	PSN	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617322	amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral Suspension	PSN	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617430	amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension	PSN	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617296	amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet	PSN	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617423	amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral Suspension	SCD	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617322	amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension	SCD	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617296	amoxicillin 500 MG / clavulanate 125 MG Oral Tablet	SCD	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617430	amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension	SCD	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617423	amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral Suspension	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617322	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral Suspension	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617430	amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617296	amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617423	amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral Suspension	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617322	amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral Suspension	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7
617430	amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension	SY	58a20183-4eb6-438e-bd1e-a74f4645bb0d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43598-221-14	43598022114	20 in 1 BOTTLE	Historical
43598-221-78	43598022178	100 in 1 BOX, UNIT-DOSE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
amoxicillin and clavulanate potassium	Preferred Pharmaceuticals, Inc.	2020-02-26	HUMAN PRESCRIPTION DRUG LABEL	8
amoxicillin and clavulanate potassium	NuCare Pharmaceuticals, Inc. \| NuCarePharmaceuticals, Inc.	2017-05-24	HUMAN PRESCRIPTION DRUG LABEL	1
amoxicillin and clavulanate potassium	NuCare Pharmaceuticals, Inc.	2017-05-09	HUMAN PRESCRIPTION DRUG LABEL	1
amoxicillin and clavulanate potassium	Dr. Reddy's Laboratories Inc \| Dr. Reddy's Laboratories Inc DBA Dr. Reddy's Laboratories Tennessee LLC \| Beecham Pharmaceuticals (PTE) Limited \| SmithKline Beecham Limited	2016-09-01	HUMAN PRESCRIPTION DRUG LABEL	7