Home NDC 70882-111 Amoxicillin and Clavulanate Potassium
Product NDC 70882-111
11-digit product format 708820111
Labeler code 70882
Product ID 70882-111_f0063b1e-af9e-474d-96b9-0b3aa1a37ea2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cambridge Therapeutics Technologies, LLC
Application ANDA065189
Marketing category ANDA
Marketing start 2005-08-23
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.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70882-111-20 Amoxicillin and Clavulanate Potassium 20 in 1 BLISTER PACK TABLET, FILM COATED 20 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70882-111 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20161216_a4c9694c-f539-470e-bfe3-8723fa1c343d.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 70882-111-20 70882011120 20 TABLET, FILM COATED in 1 BLISTER PACK (70882-111-20) 2005-08-23 0000-00-00 No No Current