Home NDC 66267-857-04 Amoxicillin and Clavulanate Potassium
Product NDC 66267-857
Requested package NDC 66267-857-04
11-digit product format 662670857
Labeler code 66267
Product ID 66267-857_a215bc78-593c-0721-e053-2a95a90af48d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amoxicillin and clavulanate potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA065117
Marketing category ANDA
Marketing start 2002-11-27
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 E Excluded after deficient or non-compliant submission was not corrected d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 E Excluded after deficient or non-compliant submission was not corrected f5e01cc5f278…a2eaf40c39c3…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 66267-857-03 2024-08-14 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. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP and For Oral Suspension 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 and other antibacterial drugs, amoxicillin and clavulanate pot 66267-857-04 2024-08-14 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. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP and For Oral Suspension 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 and other antibacterial drugs, amoxicillin and clavulanate pot 66267-857-03 2022-01-28 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. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP and For Oral Suspension 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 and other antibacterial drugs, amoxicillin and clavulanate pot 66267-857-04 2022-01-28 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. AMOXICILLIN and CLAVULANATE Potassium Tablets, USP and For Oral Suspension 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 and other antibacterial drugs, amoxicillin and clavulanate pot
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66267-857-03 Amoxicillin and Clavulanate Potassium 3 in 1 BOTTLE TABLET, FILM COATED 3 5 66267-857-04 Amoxicillin and Clavulanate Potassium 4 in 1 BOTTLE TABLET, FILM COATED 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66267-857 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] 5 Legacy NDC, 2 package rows 20240816_46dcd9a1-b560-3809-e054-00144ff88e88.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 66267-857-04 66267085704 4 TABLET, FILM COATED in 1 BOTTLE (66267-857-04) 2017-01-24 0000-00-00 No No Current