AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
60432-070
11-digit product format
604320070
Labeler code
60432
Product ID
60432-070_97bdb634-bdbf-42ab-9c14-3e3dc434ba90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Morton Grove Pharmaceutic
Application
ANDA065420
Marketing category
ANDA
Marketing start
2013-12-02
Marketing end
0000-00-00
Substance
AMOXICILLIN; CL
Active strength
600 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-clas
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60432-070DDiscontinued by firm2026-10-12
excluded packagepackage60432-07060432-070-00DDiscontinued by firm2026-10-12
excluded packagepackage60432-07060432-070-46DDiscontinued by firm2026-10-12
excluded packagepackage60432-07060432-070-47DDiscontinued by firm2026-10-12
excluded packagepackage60432-07060432-070-48DDiscontinued by firm2026-10-12
excluded packagepackage60432-07060432-070-50DDiscontinued by firm2026-10-12
excluded packagepackage60432-07060432-070-75DDiscontinued by firm2026-10-12

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 2 · 84 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 packagepackage60432-070-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-070-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-070-46d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-070-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-070-47d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60432-070-75d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-070-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-070-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-070-46f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-070-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-070-47f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60432-070-75f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-070-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-070-482ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-070-462ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-070-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-070-472ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60432-070-752ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-070-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-070-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-070-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-070-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-070-47a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60432-070-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-070-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-070-48cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-070-46cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-070-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-070-47cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60432-070-75cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-070-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-070-48cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-070-46cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-070-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-070-47cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60432-070-75cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-070-00302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-070-48302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-070-46302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-070-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-070-47302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60432-070-75302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-070-00ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-070-48ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-070-46ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-070-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-070-47ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60432-070-75ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-070-000efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-070-480efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60432-070-460efc9e666f02…f202fb6c5f17…

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
A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065420-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-0284e616aacf4f…
2026-08-18 06:07:402026-07A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-023f01610625f2…
2019-09-15 20:21 UTC2019-09A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065420-001AMOXICILLIN AND CLAVULANATE POTASSIUM600MG/5ML;EQ 42.9MG BASE/5MLFOR SUSPENSION / ORALAB2013-12-02f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09A065420-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065420-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065420-001AB1a50c72e98297…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-070-46ML - Milliliter60432-07017def5a6-0f31-4efe-898a-fc5778c813a412014-07-02
60432-070-48ML - Milliliter60432-070b88c8957-7044-4802-8373-0d68cc11fef512014-07-02
60432-070-75ML - Milliliter60432-0701c5215d6-3266-4136-9e3a-f573405064ac12014-07-02

DailyMed Socrata Ingredients#