Amoxicillin and Clavulanate Potassium

Product NDC
68788-8770
11-digit product format
687888770
Labeler code
68788
Product ID
68788-8770_0295f6ef-bd98-477a-a6d9-376561bb6d8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065373
Marketing category
ANDA
Marketing start
2024-11-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600; 42.9 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065373-001AB

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065373-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2007-11-09f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065373-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A065373-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065373-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065373-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065373-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065373-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065373-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065373-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065373-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065373-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065373-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065373-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065373-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065373-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065373-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065373-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065373-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065373-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065373-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065373-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065373-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065373-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065373-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065373-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065373-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065373-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065373-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065373-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065373-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065373-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065373-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065373-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065373-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065373-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065373-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065373-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065373-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065373-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065373-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065373-001AB1f41ea6bd6efb…

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
AMOXICILLIN600 mg/5mL
CLAVULANATE POTASSIUM42.9 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617993Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16915fe9-1ac9-4ebb-afc8-eeb89144f30cAvailable 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
68788-8770-1Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLESUSPENSION1252
68788-8770-7Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLESUSPENSION752

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8770-1ML - Milliliter68788-8770672c0b99-3b72-4006-bec1-dfb1dc4e25d412025-02-10
68788-8770-7ML - Milliliter68788-877043f10b5d-b884-4749-b322-e0f11ca79ade12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8770AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20241122_16915fe9-1ac9-4ebb-afc8-eeb89144f30c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.fc31a5df-aa1c-4b0f-8c64-a14236df4a022026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065373
application number: ANDA065373
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.16915fe9-1ac9-4ebb-afc8-eeb89144f30c2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065373
application number: ANDA065373
ndc (product): 68788-8770
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHikma Pharmaceuticals USA Inc.6339bcdb-060f-4558-9f42-6bf7f935e1382025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065373
application number: ANDA065373

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN16915fe9-1ac9-4ebb-afc8-eeb89144f30c2
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD16915fe9-1ac9-4ebb-afc8-eeb89144f30c2
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY16915fe9-1ac9-4ebb-afc8-eeb89144f30c2
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY16915fe9-1ac9-4ebb-afc8-eeb89144f30c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8770-168788877001125 mL in 1 BOTTLE (68788-8770-1) 125 ml2024-11-20NoNoCurrent
68788-8770-76878887700775 mL in 1 BOTTLE (68788-8770-7) 75 ml2024-11-20NoNoCurrent