Home NDC 61919-019 AMOXICILLIN AND CLAVULANATE POTASSIUM
Product NDC 61919-019
11-digit product format 619190019
Labeler code 61919
Product ID 61919-019_b96b2e24-4192-31e2-e053-2a95a90a2356
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DIRECT RX
Application ANDA065117
Marketing category ANDA
Marketing start 2021-01-21
Marketing end 0000-00-00
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 500 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 2022-12-31
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 · 24 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 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 61919-019-20 557ba5c1ecfa…9c80585c8c6e…
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 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27
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 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL 2002-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065117-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB RS 2002-11-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-019-20 AMOXICILLIN AND CLAVULANATE POTASSIUM 20 in 1 BOTTLE TABLET, FILM COATED 20 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMOXICILLIN ACTIVE INGREDIENT 804826J2HU AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-019 AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX] 5 Legacy NDC, 1 package rows 20240110_0173e9de-a995-4386-bb65-8fc2bbf347f9.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61919-019-20 61919001920 20 TABLET, FILM COATED in 1 BOTTLE (61919-019-20) 2021-01-21 0000-00-00 No No Current