Amoxicillin and Clavulanate Potassium

Product NDC
50090-2547
Requested package NDC
50090-2547-0
11-digit product format
500902547
Labeler code
50090
Product ID
50090-2547_109b3c53-fd71-4f23-9e2d-2a7005a8620a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065117
Marketing category
ANDA
Marketing start
2016-02-01
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-254750090-2547-0IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
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#

NDC, Related label table
NDCRelated label
50090-2547-0These highlights do not include all the information needed to use amoxicillin and clavulanate potassium safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE Potassium Tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets sho
50090-2547-1These highlights do not include all the information needed to use amoxicillin and clavulanate potassium safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE Potassium Tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets sho
50090-2547-2These highlights do not include all the information needed to use amoxicillin and clavulanate potassium safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE Potassium Tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets sho
50090-2547-3These highlights do not include all the information needed to use amoxicillin and clavulanate potassium safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE Potassium Tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets sho

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2547-0Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED2010
50090-2547-1Amoxicillin and Clavulanate Potassium21 in 1 BOTTLETABLET, FILM COATED2110
50090-2547-2Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED3010
50090-2547-3Amoxicillin and Clavulanate Potassium15 in 1 BOTTLETABLET, FILM COATED1510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2547-0EA - Each50090-25472bdf18fb-fa79-4fab-9632-d8d34013cb7c12019-03-12
50090-2547-1EA - Each50090-25479aef063e-0974-4d1b-8d22-4f4e64c9e8ac12018-11-06
50090-2547-2EA - Each50090-25471171fc4b-bce5-4094-8a78-fac7da2d9be812018-11-06
50090-2547-3EA - Each50090-2547d133ba30-3939-4403-9838-8afdd377f59c12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2547AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Legacy NDC, 4 package rows20210829_2dcf1049-fe8e-45f3-8cf4-1042c616160c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN2dcf1049-fe8e-45f3-8cf4-1042c616160c10
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD2dcf1049-fe8e-45f3-8cf4-1042c616160c10
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY2dcf1049-fe8e-45f3-8cf4-1042c616160c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2547-05009025470020 TABLET, FILM COATED in 1 BOTTLE (50090-2547-0) 2016-10-200000-00-00NoNoCurrent