Home NDC 53808-0759 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 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 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 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 53808-0759-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0759-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0759-1 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 Uploaded 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
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.
DailyMed RxNorm Mappings# 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