FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50090-3179
11-digit product format
500903179
Labeler code
50090
Product ID
50090-3179_2694cd89-604e-4636-b516-d4569d1e4c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203824
Marketing category
ANDA
Marketing start
2016-08-23
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 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
2027-12-31
Current FDA listing
Yes

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 packagepackage50090-317950090-3179-5DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-317950090-3179-5DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-317950090-3179-5DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562508Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3d1c0bb-94f3-4cfb-a4c6-233cf7e519a4Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-3179-02023-02-07These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-12023-02-07These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-22023-02-07These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-32023-02-07These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-52023-02-07These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-02023-01-30These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-12023-01-30These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-22023-01-30These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-32023-01-30These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-52023-01-30These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3179-0Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET2019
50090-3179-1Amoxicillin and Clavulanate Potassium10 in 1 BOTTLETABLET1019
50090-3179-2Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET1419
50090-3179-3Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET2819
50090-3179-5Amoxicillin and Clavulanate Potassium1 in 1 BOTTLETABLET119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3179-0EA - Each50090-317979b9d7b2-53c4-46d9-afc9-cc738b40d64b12019-05-02
50090-3179-1EA - Each50090-317904cb8bd7-c7a8-4f38-b8bd-c2ff5900588c12020-02-13
50090-3179-2EA - Each50090-3179a67778e3-c18f-4060-ad0c-e186094ad2b112020-02-13
50090-3179-3EA - Each50090-31794ff1bf20-1fb1-4479-b7c8-23544d8d6a4c12020-02-13
50090-3179-5EA - Each50090-31799358a1fa-f332-4893-91d9-98bc335abc6412020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3179AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 5 package rows20250406_a3d1c0bb-94f3-4cfb-a4c6-233cf7e519a4.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 · 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
ndc (product): 50090-3179
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3179-05009031790020 TABLET in 1 BOTTLE (50090-3179-0) 20 tablet2017-10-160000-00-00NoNoCurrent
50090-3179-15009031790110 TABLET in 1 BOTTLE (50090-3179-1) 10 tablet2017-12-220000-00-00NoNoCurrent
50090-3179-25009031790214 TABLET in 1 BOTTLE (50090-3179-2) 14 tablet2017-11-010000-00-00NoNoCurrent
50090-3179-35009031790328 TABLET in 1 BOTTLE (50090-3179-3) 28 tablet2018-03-290000-00-00NoNoCurrent
50090-3179-5500903179051 TABLET in 1 BOTTLE (50090-3179-5) 1 tablet2018-03-130000-00-00NoNoCurrent