Home NDC 50090-4922-1 Amoxicillin and Clavulanate Potassium
Product NDC 50090-4922
Requested package NDC 50090-4922-1
11-digit product format 500904922
Labeler code 50090
Product ID 50090-4922_a715fbb7-0ec4-43dd-bcd2-ec23c88c3591
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amoxicillin and clavulanate potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA065093
Marketing category ANDA
Marketing start 2015-11-01
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 2021-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 50090-4922-0 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 tablets, USP. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potass 50090-4922-1 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 tablets, USP. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potass 50090-4922-2 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 tablets, USP. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potass 50090-4922-3 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 tablets, USP. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potass
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4922-0 Amoxicillin and Clavulanate Potassium 20 in 1 BOTTLE TABLET, FILM COATED 20 2 50090-4922-1 Amoxicillin and Clavulanate Potassium 10 in 1 BOTTLE TABLET, FILM COATED 10 2 50090-4922-2 Amoxicillin and Clavulanate Potassium 14 in 1 BOTTLE TABLET, FILM COATED 14 2 50090-4922-3 Amoxicillin and Clavulanate Potassium 28 in 1 BOTTLE TABLET, FILM COATED 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4922 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 2 Legacy NDC, 4 package rows 20200226_2c306380-975c-4c74-b001-7c4421311cc4.zip
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 50090-4922-1 50090492201 10 TABLET, FILM COATED in 1 BOTTLE (50090-4922-1) 2020-02-19 0000-00-00 No No Current