Home NDC 71297-240-34 Augmentin
Product NDC 71297-240
Requested package NDC 71297-240-34
11-digit product format 712970240
Labeler code 71297
Product ID 71297-240_18975386-c292-a0cb-e063-6294a90aed18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin and Clavulanate Potassium
Dosage form FOR SUSPENSION
Route ORAL
Labeler Allegis Holdings, LLC
Application NDA050575
Marketing category NDA
Marketing start 2023-09-01
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength 125; 31.25 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 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 Augmentin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 125 mg/5mL CLAVULANATE POTASSIUM 31.25 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617302 Internal RxNorm lookup 617333 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 71297-240-34 Augmentin 75 mL in 1 BOTTLE FOR SUSPENSION 75 4 71297-240-35 Augmentin 100 mL in 1 BOTTLE FOR SUSPENSION 100 4 71297-240-36 Augmentin 150 mL in 1 BOTTLE FOR SUSPENSION 150 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71297-240 AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR SUSPENSION [ALLEGIS HOLDINGS, LLC] 4 Current NDC, 3 package rows 20240518_04a31a42-d79e-bbb4-e063-6394a90a63ee.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 71297-240-34 71297024034 75 mL in 1 BOTTLE (71297-240-34) 75 ml 2024-02-20 No No Current