Home NDC 73043-009 Amoxicillin and Clavulanate Potassium
Product NDC 73043-009
11-digit product format 730430009
Labeler code 73043
Product ID 73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Devatis, Inc.
Application ANDA210416
Marketing category ANDA
Marketing start 2024-11-01
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 400; 57 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210416-001 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.
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 2026-02-19 14:30 UTC 2026-02 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210416-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2023-12-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Amoxicillin and Clavulanate Potassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 400 mg/5mL CLAVULANATE POTASSIUM 57 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 804826J2HU Internal UNII lookup Q42OMW3AT8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617430 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 73043-009-01 Amoxicillin and Clavulanate Potassium 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 2 73043-009-02 Amoxicillin and Clavulanate Potassium 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 2 73043-009-03 Amoxicillin and Clavulanate Potassium 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73043-009 AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DEVATIS, INC.] 2 Current NDC, 3 package rows 20250316_90d0aa94-5c32-4fb7-8561-8763810d2847.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73043-009-01 73043000901 50 mL in 1 BOTTLE (73043-009-01) 50 ml 2024-11-01 No No Current 73043-009-02 73043000902 75 mL in 1 BOTTLE (73043-009-02) 75 ml 2024-11-01 No No Current 73043-009-03 73043000903 100 mL in 1 BOTTLE (73043-009-03) 100 ml 2024-11-01 No No Current