Amoxicillin and Clavulanate Potassium

Product NDC
70882-112
11-digit product format
708820112
Labeler code
70882
Product ID
70882-112_d63937ce-2eb3-4ae2-8a4d-40a2e935d06f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cambridge Therapeutics Technologies, LLC
Application
ANDA065117
Marketing category
ANDA
Marketing start
2002-11-27
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500 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
2019-12-31
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 productproduct70882-112IInactivated by FDA2026-10-05
excluded packagepackage70882-11270882-112-20IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70882-112-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70882-112-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70882-112-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70882-112-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70882-112-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70882-112-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70882-112-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70882-112-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70882-112-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70882-112-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70882-112-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70882-112-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70882-112-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70882-112-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70882-112-201332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70882-112-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70882-112-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70882-112-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70882-112-208dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70882-112-20e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70882-112-209bebd1f3094a…5416666fcb17…

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
A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-27

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 22:38:342026-08A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-2784e616aacf4f…
2026-08-18 06:07:402026-07A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORAL2002-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-273f01610625f2…
2019-09-15 20:21 UTC2019-09A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065117-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALABRS2002-11-27f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065117-001AB15bbf6a4d5a75…
2024-10-29 15:01 UTC2024-10A065117-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065117-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065117-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065117-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065117-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065117-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065117-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065117-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065117-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065117-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065117-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065117-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065117-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065117-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065117-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065117-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065117-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065117-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065117-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065117-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065117-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065117-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065117-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065117-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065117-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065117-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065117-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065117-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065117-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065117-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065117-001AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70882-112-20Amoxicillin and Clavulanate Potassium20 in 1 BLISTER PACKTABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70882-112-20EA - Each70882-112694cca66-5f09-43e3-a8a4-38abb8ba5b0612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70882-112AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC]1Legacy NDC, 1 package rows20170124_1c477549-1bbe-4065-b0f8-7514667755a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN1c477549-1bbe-4065-b0f8-7514667755a31
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD1c477549-1bbe-4065-b0f8-7514667755a31
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY1c477549-1bbe-4065-b0f8-7514667755a31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70882-112-207088201122020 in 1 BLISTER PACKHistorical