Home NDC 76420-503 Amoxicillin and Clavulanate Potassium
Product NDC 76420-503
11-digit product format 764200503
Labeler code 76420
Product ID 76420-503_1ad2509a-4b56-b766-e063-6294a90a3d7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA065189
Marketing category ANDA
Marketing start 2015-11-01
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 250; 125 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 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Amoxicillin and Clavulanate Potassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 250 mg/1 CLAVULANATE POTASSIUM 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 804826J2HU Internal UNII lookup Q42OMW3AT8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562251 Internal RxNorm lookup 562508 Internal RxNorm lookup 617296 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76420-503-30 Amoxicillin and Clavulanate Potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-503 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [ASCLEMED USA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240615_a94cfba3-27ed-46a3-81ef-e9b80187c207.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 Marketing start Marketing end Sample Exclude flag Status 76420-503-30 76420050330 30 TABLET, FILM COATED in 1 BOTTLE (76420-503-30) 2019-10-15 0000-00-00 No No Current