Home NDC 76420-608 Amoxicillin and Clavulanate Potassium
Product NDC 76420-608
11-digit product format 764200608
Labeler code 76420
Product ID 76420-608_04ab2de4-f498-1b52-e063-6394a90a5fc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA065101
Marketing category ANDA
Marketing start 2002-10-31
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 500; 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065101-001 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 · 45 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 2026-11-14 07:37:17 2026-10 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065101-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE TABLET / ORAL AB 2002-10-30 3bdfa0b2c4d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Amoxicillin and Clavulanate Potassium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 500 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 76420-608-20 Amoxicillin and Clavulanate Potassium 20 in 1 BOTTLE TABLET, FILM COATED 20 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-608 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [ASCLEMED USA, INC.] 1 Current NDC, 1 package rows 20230907_8c4125d4-d074-40d4-9def-d3a528fc8c8e.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM PD-Rx Pharmaceuticals, Inc. cc445a39-d84c-4b76-9fb8-ae302e7cd96b 2025-10-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101 Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM Proficient Rx LP 482511ed-4531-45ec-a4eb-c600aeb03325 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101 Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM Teva Pharmaceuticals USA, Inc. 963e7bea-ff5d-420a-9cb2-e4aefb534b33 2024-06-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101 Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM Asclemed USA, Inc. 8c4125d4-d074-40d4-9def-d3a528fc8c8e 2023-09-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065101 application number: ANDA065101 ndc (product): 76420-608
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 76420-608-20 76420060820 20 TABLET, FILM COATED in 1 BOTTLE (76420-608-20) 2023-09-06 No No Current