Amoxicillin and Clavulanate Potassium

Product NDC
63187-542
11-digit product format
631870542
Labeler code
63187
Product ID
63187-542_51ae03ae-99b0-47e9-ae80-0e8e7b1fc7bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065098
Marketing category
ANDA
Marketing start
2004-08-13
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
200 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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-542DDiscontinued by firm2026-10-05
excluded packagepackage63187-54263187-542-00DDiscontinued by firm2026-10-05

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
A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16
A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065098-001AB
A065098-002AB

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 22:38:342026-08A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1684e616aacf4f…
2026-09-14 22:38:342026-08A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1684e616aacf4f…
2026-08-18 06:07:402026-07A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1674a2ff9319b5…

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 22:38:342026-08A065098-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065098-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A065098-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065098-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065098-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065098-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065098-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065098-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065098-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065098-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065098-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065098-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065098-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065098-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065098-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065098-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065098-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065098-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065098-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065098-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065098-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065098-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065098-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065098-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065098-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065098-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065098-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065098-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065098-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065098-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065098-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065098-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065098-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065098-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065098-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065098-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065098-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065098-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065098-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065098-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
RASPBERRYINACTIVE INGREDIENT4N14V5R27WAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-542AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]3Legacy NDC20210114_0f263ead-5be2-435e-9e5d-8f23fb1707e3.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 POTASSIUMA-S Medication Solutions029a49f2-2132-4160-a0d6-2d108a456a222023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065098
application number: ANDA065098

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-542-0063187054200100 mL in 1 BOTTLE (63187-542-00) 100 ml2018-12-010000-00-00NoNoCurrent