Amoxicillin and Clavulanate Potassium

Product NDC
55700-653
Requested package NDC
55700-653-20
11-digit product format
557000653
Labeler code
55700
Product ID
55700-653_5fc90565-f545-48dc-af79-39c847f80700
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA203824
Marketing category
ANDA
Marketing start
2018-07-13
Marketing end
2021-10-31
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 mg/1; mg/1
Pharmacologic classes
beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage55700-65355700-653-20DDiscontinued by firm2026-08-07

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 · 12 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…

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
A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203824-001AB

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 UTC2026-02A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-233f01610625f2…
2019-09-15 20:21 UTC2019-09A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203824-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALAB2016-08-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203824-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203824-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203824-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203824-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203824-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203824-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203824-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203824-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203824-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203824-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203824-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203824-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203824-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203824-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203824-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203824-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203824-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203824-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203824-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203824-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203824-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203824-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203824-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203824-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203824-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203824-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203824-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203824-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203824-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203824-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203824-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203824-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203824-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203824-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203824-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203824-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203824-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203824-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203824-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203824-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-653-14EA - Each55700-653cae37f9f-2bec-45f3-a912-3173b0cc89f412018-09-05
55700-653-20EA - Each55700-653a793f131-9776-42fe-a716-25aeb4b2f22512018-08-13

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.d213685c-5e67-4130-b00b-7626685dfa162026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.6a078e7d-f942-4185-a131-50215d8e0a1e2026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.f229e8b4-7045-4c0d-9214-890c0bda3c2a2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a42026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.8dba4e86-5f79-0bea-e053-2a95a90a9e2d2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.9015d3dc-1ab4-2582-e053-2995a90a16792025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.e5b0770d-1301-498e-a4ed-41874d7bf2252025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHikma Pharmaceuticals USA Inc.52ab3500-d088-4693-acea-9b83c0843f662025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPb0d7eb3e-706a-482b-b106-9c137be55bb62025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions67b8567a-bab7-4859-88d6-c2ea695b9f0a2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.9263495c-310a-c20e-e053-2995a90a2e872024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203824
application number: ANDA203824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-653-205570006532020 TABLET in 1 BOTTLE (55700-653-20) 20 tablet2018-07-132021-10-31NoNoCurrent