Home NDC 60687-803 Amoxicillin and Clavulanate Potassium
Product NDC 60687-803
11-digit product format 606870803
Labeler code 60687
Product ID 60687-803_4c5fbf4c-ad51-58fd-e063-6294a90a8133
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA091568
Marketing category ANDA
Marketing start 2024-07-26
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 875; 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 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 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091568-001 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 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091568-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB 2012-01-20 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.
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 875 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 Q42OMW3AT8 Internal UNII lookup 804826J2HU 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 60687-803-01 Amoxicillin and Clavulanate Potassium 100 in 1 CARTON TABLET, FILM COATED 100 4 60687-803-11 Amoxicillin and Clavulanate Potassium 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-803 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 Current NDC, 2 package rows 20241215_4966a3f2-eed2-4081-ba88-310a3d1964b4.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 2 of 2 · 24 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60687-803-01 60687080301 100 BLISTER PACK in 1 CARTON (60687-803-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-803-11) 100 blister pack 2024-07-26 No No Current 60687-803-11 60687080311 1 in 1 BLISTER PACK Historical