amoxicillin and clavulanate potassium

Product NDC
43598-208
11-digit product format
435980208
Labeler code
43598
Product ID
43598-208_4291f971-d386-411e-8d06-95be682a3961
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
NDA050725
Marketing category
NDA
Marketing start
1990-10-22
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
400 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43598-208IInactivated by FDA2026-10-05
excluded packagepackage43598-20843598-208-50IInactivated by FDA2026-10-05
excluded packagepackage43598-20843598-208-51IInactivated by FDA2026-10-05
excluded packagepackage43598-20843598-208-52IInactivated 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 2 · 88 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 packagepackage43598-208-51d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-208-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-208-52d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-208-51f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-208-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-208-52f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-208-512ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-208-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-208-522ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-208-51a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-208-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-208-52a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-208-51cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-208-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-208-52cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-208-51cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-208-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-208-52cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-208-51302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-208-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-208-52302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-208-51ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-208-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-208-52ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-208-510efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-208-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-208-520efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-208-51ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-208-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-208-52ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-208-51367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-208-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-208-52367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-208-51557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-208-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-208-52557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43598-208-518af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43598-208-508af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43598-208-528af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43598-208-51834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43598-208-50834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43598-208-52834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43598-208-511332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43598-208-501332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43598-208-521332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050725-001AUGMENTIN '200'AMOXICILLIN; CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31
N050725-002AUGMENTIN '400'AMOXICILLIN; CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3184e616aacf4f…
2026-09-14 22:38:342026-08N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3184e616aacf4f…
2026-08-18 06:07:402026-07N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3174a2ff9319b5…

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-208-502020-01-31C16284748780-19d75b9d0-4c36-f424-e053-dadaa90a57ceThese 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. A moxicillin and Clavulanate Potassium Tablets, Powder for Oral Suspension and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate
43598-208-512020-01-31C16284748780-19d75b9d0-4c36-f424-e053-dadaa90a57ceThese 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. A moxicillin and Clavulanate Potassium Tablets, Powder for Oral Suspension and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate
43598-208-522020-01-31C16284748780-19d75b9d0-4c36-f424-e053-dadaa90a57ceThese 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. A moxicillin and Clavulanate Potassium Tablets, Powder for Oral Suspension and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-208-50amoxicillin and clavulanate potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION507
43598-208-51amoxicillin and clavulanate potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION757
43598-208-52amoxicillin and clavulanate potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-208-50ML - Milliliter43598-20840513295-b245-4ec9-af60-19a7d57a209312012-07-24
43598-208-51ML - Milliliter43598-208f846cbbb-1f70-458a-bf6f-253f14c6ce0712012-07-24
43598-208-52ML - Milliliter43598-208d6790a21-87b7-4279-ae69-d1b10f9bc88212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-208AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]7Legacy NDC, 3 package rows20160913_58a20183-4eb6-438e-bd1e-a74f4645bb0d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP1f252ad3-373c-4a6d-96e7-53ba820d201b2019-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 050725
application number: NDA050725

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN1f252ad3-373c-4a6d-96e7-53ba820d201b4
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD1f252ad3-373c-4a6d-96e7-53ba820d201b4
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY1f252ad3-373c-4a6d-96e7-53ba820d201b4
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY1f252ad3-373c-4a6d-96e7-53ba820d201b4
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSNcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSNcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCDcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCDcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNf0c660da-4198-4d04-87e9-5d6a7b6f75cf1
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDf0c660da-4198-4d04-87e9-5d6a7b6f75cf1
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYf0c660da-4198-4d04-87e9-5d6a7b6f75cf1
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYf0c660da-4198-4d04-87e9-5d6a7b6f75cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
43598-208-504359802085050 mL in 1 BOTTLE50 mlHistorical
43598-208-514359802085175 mL in 1 BOTTLE75 mlHistorical
43598-208-5243598020852100 mL in 1 BOTTLE100 mlHistorical