Amoxicillin and Clavulanate Potassium

Product NDC
63187-826
11-digit product format
631870826
Labeler code
63187
Product ID
63187-826_2797b8b4-eac7-419e-b7da-a6e7493661c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065191
Marketing category
ANDA
Marketing start
2007-12-01
Substance
AMOXICILLIN; CLAVULANIC ACID
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25
A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065191-001AB
A065191-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2584e616aacf4f…
2026-09-14 22:38:342026-08A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2584e616aacf4f…
2026-08-18 06:07:402026-07A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25caaa826d4ba7…
2026-08-18 06:07:402026-07A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065191-001AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065191-002AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2005-01-2574a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065191-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065191-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A065191-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065191-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065191-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065191-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065191-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065191-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065191-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065191-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065191-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065191-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065191-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065191-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065191-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065191-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065191-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065191-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065191-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065191-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065191-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065191-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065191-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065191-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065191-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065191-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065191-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065191-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065191-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065191-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065191-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065191-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065191-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065191-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065191-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065191-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065191-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065191-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065191-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065191-002AB174a2ff9319b5…

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
Amoxicillin and Clavulanate Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN400 mg/5mL
CLAVULANIC ACID57 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
23521W1S24Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617430Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4655e0ea-f7d5-4f7c-bf7b-266337bc05b8Available 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
63187-826-00Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-826-00ML - Milliliter63187-826785a74ae-846a-4759-9bf3-fcde3486c57312017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-826AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]3Current NDC, Legacy NDC, 1 package rows20191113_4655e0ea-f7d5-4f7c-bf7b-266337bc05b8.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.2c7a4de8-002a-472c-90d8-4c39a1f188c32026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065191
application number: ANDA065191
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions483f6fca-e04e-4086-aa44-a361322b811d2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065191
application number: ANDA065191
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHikma Pharmaceuticals USA Inc.240bcdcb-31d9-40a0-87e1-bd16264a2e202025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065191
application number: ANDA065191
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.5d074fe6-1ee0-40d8-e053-2a91aa0a75492024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065191
application number: ANDA065191
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP4655e0ea-f7d5-4f7c-bf7b-266337bc05b82019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065191
application number: ANDA065191
ndc (product): 63187-826

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN4655e0ea-f7d5-4f7c-bf7b-266337bc05b83
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD4655e0ea-f7d5-4f7c-bf7b-266337bc05b83
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY4655e0ea-f7d5-4f7c-bf7b-266337bc05b83
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY4655e0ea-f7d5-4f7c-bf7b-266337bc05b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-826-0063187082600100 mL in 1 BOTTLE (63187-826-00) 100 ml2017-03-010000-00-00NoNoCurrent