Home NDC 72508-012-05 AUGMENTIN
Product NDC 72508-012
Requested package NDC 72508-012-05
11-digit product format 725080012
Labeler code 72508
Product ID 72508-012_ec33a4fa-973d-4df0-9ff6-05afbd3eefe0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amoxicillin and clavulanate potassium
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Neopharma Inc
Application NDA050575
Marketing category NDA
Marketing start 2019-03-01
Marketing end 2021-09-01
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 125 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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 72508-012-01 2021-08-10 These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by 72508-012-03 2021-08-10 These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by 72508-012-05 2021-08-10 These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by 72508-012-01 2021-07-23 These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by 72508-012-03 2021-07-23 These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by 72508-012-05 2021-07-23 These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72508-012-05 72508001205 150 mL in 1 BOTTLE (72508-012-05) 150 ml 2019-03-01 2021-09-01 No No Current