Amoxicillin and Clavulanate Potassium

Product NDC
65862-534
11-digit product format
658620534
Labeler code
65862
Product ID
65862-534_4bd68235-4588-4e1a-9bac-b3d98481fd03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA201090
Marketing category
ANDA
Marketing start
2011-12-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
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
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
A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20
A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201090-001AB
A201090-002AB

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 UTC2026-02A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201090-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A201090-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2011-12-20782e0a99824c…

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 UTC2026-02A201090-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201090-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201090-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201090-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201090-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201090-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201090-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201090-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201090-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201090-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201090-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201090-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201090-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201090-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201090-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201090-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201090-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201090-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201090-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201090-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201090-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201090-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201090-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201090-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201090-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201090-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201090-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201090-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201090-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201090-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201090-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201090-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201090-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201090-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201090-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201090-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201090-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201090-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201090-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201090-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN400 mg/5mL
CLAVULANATE POTASSIUM57 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
617423Internal RxNorm lookup
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
ab1dbe70-696f-4ff9-a0c7-7406bff590aeAvailable 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
65862-534-01Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10014
65862-534-50Amoxicillin and Clavulanate Potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5014
65862-534-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-534-01ML - Milliliter65862-53425276cb7-787c-4741-9f5b-33ddeaedc47c12012-07-24
65862-534-50ML - Milliliter65862-534e99c0ab1-2a63-4780-9803-587aa605b96012012-07-24
65862-534-75ML - Milliliter65862-534ead24da3-d518-40af-bc4f-3aa709091a9d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-534AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 3 package rows20240620_ab1dbe70-696f-4ff9-a0c7-7406bff590ae.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHAWAII REPACK, INC.7fb0f56e-c098-49e4-b075-2eb8936582aa2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsce488c24-2ec5-4d1b-b446-90f2497aa15d2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.ca664448-12fb-0c6f-e053-2995a90a262c2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.618953a3-0256-42ce-9155-d35325f017aa2026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.30446852-9a54-4d16-ba12-56ffd01499852026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions77126eee-9534-4e80-9d11-ec78ec66c8262026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.30144e2e-d336-8fa3-e063-6394a90a60682025-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin/Clav Pot Oral SuspAMOXICILLIN/CLAV POT ORAL SUSPDirect_Rxe5bd9918-b073-c50b-e053-2a95a90aaeb72025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.abbebdc1-4410-76af-e053-2a95a90acb9c2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.fc5dc69a-3c23-49fc-b80f-1412aebc9b762024-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPaad174d9-2c46-49aa-9a62-61063f405c532024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNorthStar Rx LLCf0a6d21d-203f-4fde-b010-a2730b86b4912024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAurobindo Pharma Limitedab1dbe70-696f-4ff9-a0c7-7406bff590ae2024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
ndc (product): 65862-534
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions2718248d-d948-466e-959b-1a972519f1082024-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions4937611d-bd61-4538-ad1e-bd67e95279552024-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions61f9224b-a91b-4154-a7f3-22c14601230f2023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201090
application number: ANDA201090

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSNab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCDab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSYab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSYab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN2718248d-d948-466e-959b-1a972519f10810
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD2718248d-d948-466e-959b-1a972519f10810
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY2718248d-d948-466e-959b-1a972519f10810
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY2718248d-d948-466e-959b-1a972519f10810
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNabbebdc1-4410-76af-e053-2a95a90acb9c4
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDabbebdc1-4410-76af-e053-2a95a90acb9c4
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYabbebdc1-4410-76af-e053-2a95a90acb9c4
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYabbebdc1-4410-76af-e053-2a95a90acb9c4
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNaad174d9-2c46-49aa-9a62-61063f405c533
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDaad174d9-2c46-49aa-9a62-61063f405c533
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYaad174d9-2c46-49aa-9a62-61063f405c533
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYaad174d9-2c46-49aa-9a62-61063f405c533
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNe5bd9918-b073-c50b-e053-2a95a90aaeb72
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDe5bd9918-b073-c50b-e053-2a95a90aaeb72
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYe5bd9918-b073-c50b-e053-2a95a90aaeb72
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYe5bd9918-b073-c50b-e053-2a95a90aaeb72
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSNfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN52b9defd-244a-444f-96d3-b747622dc2891
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNe1013b38-446b-4faf-973d-272d90ff309a1
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNd79a5d6c-753f-807a-e053-2995a90a79fa1
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCDfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDe1013b38-446b-4faf-973d-272d90ff309a1
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD52b9defd-244a-444f-96d3-b747622dc2891
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDd79a5d6c-753f-807a-e053-2995a90a79fa1
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY52b9defd-244a-444f-96d3-b747622dc2891
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYe1013b38-446b-4faf-973d-272d90ff309a1
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYd79a5d6c-753f-807a-e053-2995a90a79fa1
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY52b9defd-244a-444f-96d3-b747622dc2891
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYe1013b38-446b-4faf-973d-272d90ff309a1
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYd79a5d6c-753f-807a-e053-2995a90a79fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-534-0165862053401100 mL in 1 BOTTLE (65862-534-01) 100 ml2011-12-200000-00-00NoNoCurrent
65862-534-506586205345050 mL in 1 BOTTLE (65862-534-50) 50 ml2011-12-200000-00-00NoNoCurrent
65862-534-756586205347575 mL in 1 BOTTLE (65862-534-75) 75 ml2011-12-200000-00-00NoNoCurrent