Home NDC 68071-3774-5 AMOXICILLIN AND CLAVULANATE POTASSIUM
Product NDC 68071-3774
Requested package NDC 68071-3774-5
11-digit product format 680713774
Labeler code 68071
Product ID 68071-3774_2bb03d3b-5d45-bc4a-e063-6394a90a656a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amoxicillin and clavulanate potassium
Dosage form FOR SUSPENSION
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application NDA050755
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-09-19
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 600; 42.9 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 N050755-001 AUGMENTIN ES-600 AMOXICILLIN; CLAVULANATE POTASSIUM 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050755-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL RLD 2001-06-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL RLD 2001-06-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL RLD 2001-06-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL RLD 2001-06-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050755-001 AUGMENTIN ES-600 600MG/5ML;EQ 42.9MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 2001-06-22 cb3db0bc1861…
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 600 mg/5mL CLAVULANATE POTASSIUM 42.9 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 617993 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 68071-3774-5 AMOXICILLIN AND CLAVULANATE POTASSIUM 125 mL in 1 BOTTLE FOR SUSPENSION 125 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3774 AMOXICILLIN AND CLAVULANATE POTASSIUM FOR SUSPENSION [NUCARE PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20250116_2bb03d3b-5d44-bc4a-e063-6394a90a656a.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 · 4 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 68071-3774-5 68071377405 125 mL in 1 BOTTLE (68071-3774-5) 125 ml 2025-01-14 No No Current