Amoxicillin and Clavulanate Potassium

Product NDC
72789-253
11-digit product format
727890253
Labeler code
72789
Product ID
72789-253_4bac4b71-1e5f-b53e-e063-6394a90a46aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

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
6a078e7d-f942-4185-a131-50215d8e0a1eAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-253-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLE, PLASTICTABLET2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-253-20EA - Each72789-253c0520fb6-df2c-4257-8f1a-7f0157a726d112022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-253AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 1 package rows20250207_6a078e7d-f942-4185-a131-50215d8e0a1e.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
ndc (product): 72789-253
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN6a078e7d-f942-4185-a131-50215d8e0a1e15
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD6a078e7d-f942-4185-a131-50215d8e0a1e15
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6a078e7d-f942-4185-a131-50215d8e0a1e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-253-207278902532020 TABLET in 1 BOTTLE, PLASTIC (72789-253-20) 20 tablet2022-06-290000-00-00NoNoCurrent