Home NDC 81964-204-10 AMOXICILLIN AND CLAVULANATE POTASSIUM
Product NDC 81964-204
Requested package NDC 81964-204-10
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 45 .
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 · 90 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 2026-11-14 07:37:17 2026-10 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 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
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 562508 Internal RxNorm lookup 617302 Internal RxNorm lookup 617322 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 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
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 81964-204-10 81964020410 100 mL in 1 BOTTLE (81964-204-10) 100 ml 2022-12-05 0000-00-00 No No Current