Amoxicillin and Clavulanate Potassium

Product NDC
0781-1943
11-digit product format
007811943
Labeler code
0781
Product ID
0781-1943_047eb353-1ca4-419b-947c-4d418f87c22a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA090227
Marketing category
ANDA
Marketing start
2010-04-21
Substance
AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM
Active strength
562.5; 437.5; 62.5 mg/1; mg/1; mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALABRS2010-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090227-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALABRS2010-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALAB2010-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALAB2010-04-213f01610625f2…
2019-09-15 20:21 UTC2019-09A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALAB2010-04-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALAB2010-04-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090227-001AB1011fe1cb6892…
2019-12-13 00:20 UTC2019-12A090227-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A090227-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090227-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090227-001AB1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090227-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN562.5 mg/1
AMOXICILLIN SODIUM437.5 mg/1
CLAVULANATE POTASSIUM62.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
804826J2HUInternal UNII lookup
544Y3D6MYHInternal 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
617995Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e41387c8-2c74-4990-831f-64dc921ee138Available 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
0781-1943-39Amoxicillin and Clavulanate Potassium40 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL4027
0781-1943-82Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL2827

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1943-39EA - Each0781-1943e931b958-2f91-4a8a-93e6-7e9797ee2f4912012-07-24
0781-1943-82EA - Each0781-19436c3fa966-8d3c-41cf-8cf8-10935e6880bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
AMOXICILLIN SODIUMACTIVE INGREDIENT544Y3D6MYHAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1943AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]26Current NDC, Legacy NDC, 2 package rows20250413_e41387c8-2c74-4990-831f-64dc921ee138.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLCcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090227
application number: ANDA090227
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Ince41387c8-2c74-4990-831f-64dc921ee1382025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090227
application number: ANDA090227
ndc (product): 0781-1943

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617995amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral TabletPSNe41387c8-2c74-4990-831f-64dc921ee13827
61799512 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral TabletSCDe41387c8-2c74-4990-831f-64dc921ee13827
617995amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral TabletSYe41387c8-2c74-4990-831f-64dc921ee13827
617995amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral TabletPSNcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272
61799512 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral TabletSCDcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272
617995amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral TabletSYcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-1943-390078119433940 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39) 2010-04-210000-00-00NoNoCurrent
0781-1943-820078119438228 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82) 2010-04-210000-00-00NoNoCurrent