Amoxicillin and Clavulanate Potassium

Product NDC
59651-026
11-digit product format
596510026
Labeler code
59651
Product ID
59651-026_8c4f5611-f65b-42c2-8412-e616f149ee90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209371
Marketing category
ANDA
Marketing start
2019-04-19
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19
A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209371-001AB
A209371-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209371-001AMOXICILLIN AND CLAVULANATE POTASSIUM125MG/5ML;EQ 31.25MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A209371-002AMOXICILLIN AND CLAVULANATE POTASSIUM250MG/5ML;EQ 62.5MG BASE/5MLFOR SUSPENSION / ORALAB2019-04-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209371-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209371-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209371-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209371-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209371-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209371-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209371-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209371-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209371-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209371-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209371-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209371-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209371-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209371-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209371-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209371-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209371-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209371-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209371-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209371-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209371-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209371-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209371-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209371-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209371-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209371-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209371-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209371-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209371-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209371-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209371-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209371-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209371-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209371-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209371-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209371-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209371-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209371-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209371-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209371-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 mg/5mL
CLAVULANATE POTASSIUM62.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
804826J2HUInternal UNII lookup
Q42OMW3AT8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617302Internal RxNorm lookup
617322Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ae0c95f-7ffa-4317-9fea-4d07b86bee72Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-026-01Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1007
59651-026-55Amoxicillin and Clavulanate Potassium150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1507
59651-026-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION757

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-026-01ML - Milliliter59651-02673ba602b-44a3-4ee7-9bf3-5b2430c990c112019-08-06
59651-026-55ML - Milliliter59651-02603bc1c72-081c-411e-9284-0ae9f69bee2512019-08-06
59651-026-75ML - Milliliter59651-0263f8481ee-4183-453e-bb6e-b0f49b6ef16312019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-026AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 3 package rows20240601_3ae0c95f-7ffa-4317-9fea-4d07b86bee72.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAurobindo Pharma Limited3ae0c95f-7ffa-4317-9fea-4d07b86bee722024-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209371
application number: ANDA209371
ndc (product): 59651-026

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617302amoxicillin 125 MG / clavulanic acid 31.25 MG in 5 mL Oral SuspensionPSN3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSN3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617302amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral SuspensionSCD3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCD3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617302amoxicillin (as amoxicillin trihydrate) 25 MG/ML / clavulanate (as clavulanate potassium) 6.25 MG/ML Oral SuspensionSY3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSY3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617302amoxicillin 125 MG / clavulanic acid 31.25 MG per 5 ML Oral SuspensionSY3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSY3ae0c95f-7ffa-4317-9fea-4d07b86bee727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-026-0159651002601100 mL in 1 BOTTLE (59651-026-01) 100 ml2019-04-190000-00-00NoNoCurrent
59651-026-5559651002655150 mL in 1 BOTTLE (59651-026-55) 150 ml2019-04-190000-00-00NoNoCurrent
59651-026-755965100267575 mL in 1 BOTTLE (59651-026-75) 75 ml2019-04-190000-00-00NoNoCurrent