Home NDC 81964-221 AMOXICILLIN AND CLAVULANATE POTASSIUM
Product NDC 81964-221
11-digit product format 819640221
Labeler code 81964
Product ID 81964-221_5bba212f-9bf8-29b5-e063-6394a90a8cd2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amoxicillin and clavulanate potassium
Dosage form TABLET, COATED
Route ORAL
Labeler USAntibiotics, LLC
Application NDA050720
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-11-21
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 N050720-001 AUGMENTIN '875' AMOXICILLIN; CLAVULANATE POTASSIUM 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050720-001 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 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050720-001 AUGMENTIN '875' 875MG;EQ 125MG BASE TABLET / ORAL AB RLD 1996-02-13 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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81964-221-01 AMOXICILLIN AND CLAVULANATE POTASSIUM 100 in 1 BOTTLE TABLET, COATED 100 5 81964-221-14 AMOXICILLIN AND CLAVULANATE POTASSIUM 20 in 1 BOTTLE TABLET, COATED 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81964-221 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED AMOXICILLIN AND CLAVULANATE POTASSIUM FOR SUSPENSION [USANTIBIOTICS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240518_c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3.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 · 3 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 81964-221-01 81964022101 100 TABLET, COATED in 1 BOTTLE (81964-221-01) 2024-05-01 No No Current 81964-221-14 81964022114 20 TABLET, COATED in 1 BOTTLE (81964-221-14) 2022-11-21 0000-00-00 No No Current