Amoxicillin and Clavulanate Potassium

Product NDC
0781-1831
11-digit product format
007811831
Labeler code
0781
Product ID
0781-1831_6a6233c9-2bba-4d8c-9bfa-e5c5055cf91f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065064
Marketing category
ANDA
Marketing start
2002-03-15
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500; 125 mg/1; mg/1
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 42.

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
A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065064-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-153f01610625f2…
2019-09-15 20:21 UTC2019-09A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065064-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065064-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065064-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065064-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065064-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065064-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065064-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065064-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065064-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065064-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065064-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065064-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065064-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065064-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065064-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065064-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065064-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065064-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065064-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065064-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065064-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065064-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065064-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065064-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065064-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065064-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065064-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065064-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065064-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065064-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065064-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065064-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065064-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065064-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065064-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065064-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065064-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065064-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065064-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065064-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1
CLAVULANATE POTASSIUM125 mg/1

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562251Internal RxNorm lookup
562508Internal RxNorm lookup
617296Internal RxNorm lookup
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
7cba82f0-9886-46e9-8dbd-43a448aade29Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0781-1831-01Amoxicillin and Clavulanate Potassium100 in 1 BOTTLETABLET, FILM COATED10027
0781-1831-13Amoxicillin and Clavulanate Potassium100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10027
0781-1831-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED2027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1831-01EA - Each0781-18316eb60ffa-dc2a-482f-a230-79adfe672eaf12022-11-07
0781-1831-20EA - Each0781-1831e4bd968a-d9ba-419a-9305-bafdddaf479212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
BANANAINACTIVE INGREDIENT4AJZ4765R9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CHERRYINACTIVE INGREDIENTBUC5I9595WAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1831AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]26Current NDC, Legacy NDC, 3 package rows20241128_7cba82f0-9886-46e9-8dbd-43a448aade29.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack22cd4e96-2288-470c-9264-8058cd7db9b02025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackf748b118-6d50-487a-824d-1c92ab2028c02025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Inc7cba82f0-9886-46e9-8dbd-43a448aade292025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
ndc (product): 0781-1831
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRxcdc6d30a-754e-6672-e053-2a95a90afa7f2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.a94cfba3-27ed-46a3-81ef-e9b80187c2072024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack71812ac4-9264-49f2-b9ab-ea1efd1af4522024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP01b30abb-db63-4257-9fe2-9107bb0bd69c2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN71812ac4-9264-49f2-b9ab-ea1efd1af452101
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD71812ac4-9264-49f2-b9ab-ea1efd1af452101
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY71812ac4-9264-49f2-b9ab-ea1efd1af452101
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNf748b118-6d50-487a-824d-1c92ab2028c0100
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN22cd4e96-2288-470c-9264-8058cd7db9b0100
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDf748b118-6d50-487a-824d-1c92ab2028c0100
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD22cd4e96-2288-470c-9264-8058cd7db9b0100
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY22cd4e96-2288-470c-9264-8058cd7db9b0100
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYf748b118-6d50-487a-824d-1c92ab2028c0100
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY7cba82f0-9886-46e9-8dbd-43a448aade2927
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7cba82f0-9886-46e9-8dbd-43a448aade2927
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNcdc6d30a-754e-6672-e053-2a95a90afa7f4
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDcdc6d30a-754e-6672-e053-2a95a90afa7f4
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYcdc6d30a-754e-6672-e053-2a95a90afa7f4
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN01b30abb-db63-4257-9fe2-9107bb0bd69c3
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN9158d6a2-7c88-4cd9-bb34-899438ddf4db3
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN9158d6a2-7c88-4cd9-bb34-899438ddf4db3
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD01b30abb-db63-4257-9fe2-9107bb0bd69c3
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD9158d6a2-7c88-4cd9-bb34-899438ddf4db3
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD9158d6a2-7c88-4cd9-bb34-899438ddf4db3
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY9158d6a2-7c88-4cd9-bb34-899438ddf4db3
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY01b30abb-db63-4257-9fe2-9107bb0bd69c3
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY9158d6a2-7c88-4cd9-bb34-899438ddf4db3
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNd6f7619e-9476-91fa-e053-2995a90a8fed2
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDd6f7619e-9476-91fa-e053-2995a90a8fed2
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd6f7619e-9476-91fa-e053-2995a90a8fed2
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN266b5ec9-4159-b073-e063-6394a90aec621
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD266b5ec9-4159-b073-e063-6394a90aec621
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY266b5ec9-4159-b073-e063-6394a90aec621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-1831-0100781183101100 TABLET, FILM COATED in 1 BOTTLE (0781-1831-01) 2022-09-200000-00-00NoNoCurrent
0781-1831-1300781183113100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-1831-13) 2002-03-150000-00-00NoNoCurrent
0781-1831-200078118312020 TABLET, FILM COATED in 1 BOTTLE (0781-1831-20) 2002-03-150000-00-00NoNoCurrent