Home NDC 81964-204 AMOXICILLIN AND CLAVULANATE POTASSIUM
Product NDC 81964-204
11-digit product format 819640204
Labeler code 81964
Product ID 81964-204_5bba212f-9bf8-29b5-e063-6394a90a8cd2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form FOR SUSPENSION
Route ORAL
Labeler USAntibiotics, LLC
Application NDA050575
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-12-05
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 250; 62.5 mg/5mL; mg/5mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050575-001 AUGMENTIN '125' AMOXICILLIN; CLAVULANATE POTASSIUM 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 N050575-002 AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 250 mg/5mL CLAVULANATE POTASSIUM 62.5 mg/5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81964-204-07 AMOXICILLIN AND CLAVULANATE POTASSIUM 75 mL in 1 BOTTLE FOR SUSPENSION 75 5 81964-204-10 AMOXICILLIN AND CLAVULANATE POTASSIUM 100 mL in 1 BOTTLE FOR SUSPENSION 100 5 81964-204-15 AMOXICILLIN AND CLAVULANATE POTASSIUM 150 mL in 1 BOTTLE FOR SUSPENSION 150 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81964-204 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED AMOXICILLIN AND CLAVULANATE POTASSIUM FOR SUSPENSION [USANTIBIOTICS, LLC] 4 Current NDC, Legacy NDC, 3 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Augmentin AMOXICILLIN AND CLAVULANATE POTASSIUM Allegis Holdings, LLC 04a31a42-d79e-bbb4-e063-6394a90a63ee 2024-05-16 Warnings, Adverse reactions Exact identifier application applno (NDA): 050575 application number: NDA050575
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 81964-204-07 81964020407 75 mL in 1 BOTTLE (81964-204-07) 75 ml 2022-12-05 0000-00-00 No No Current 81964-204-10 81964020410 100 mL in 1 BOTTLE (81964-204-10) 100 ml 2022-12-05 0000-00-00 No No Current 81964-204-15 81964020415 150 mL in 1 BOTTLE (81964-204-15) 150 ml 2022-12-05 0000-00-00 No No Current