Home NDC 80425-0217 Amoxicillin and Clavulanate Potassium
Product NDC 80425-0217
11-digit product format 804250217
Labeler code 80425
Product ID 80425-0217_f1d6f7ac-c13d-870d-e053-2a95a90ae2ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA065093
Marketing category ANDA
Marketing start 2023-01-04
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 No
Listing certified through 2024-12-31
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 · 18 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 80425-0217-1 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 80425-0217-1 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 80425-0217-1 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 80425-0217-1 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 80425-0217-1 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 80425-0217-1 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 80425-0217-1 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 80425-0217-1 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 80425-0217-1 0efc9e666f02…f202fb6c5f17…
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 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065093-001 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 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065093-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2002-11-21 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 80425-0217-1 80425021701 20 TABLET, FILM COATED in 1 BOTTLE (80425-0217-1) 2023-01-04 0000-00-00 No No Current