Amoxicillan

Product NDC
51655-159
11-digit product format
516550159
Labeler code
51655
Product ID
51655-159_9c806097-3e17-4611-b18d-ec76528f20eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillan
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals,LLC
Application
ANDA062058
Marketing category
ANDA
Marketing start
2014-07-18
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-159DDiscontinued by firm2026-08-17
excluded packagepackage51655-15951655-159-03DDiscontinued by firm2026-08-17

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 · 42 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 packagepackage51655-159-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-159-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-159-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-159-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-159-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-159-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-159-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-159-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-159-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-159-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-159-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-159-03557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51655-159-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-159-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-159-031332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-159-03fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-159-0386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-159-03bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-159-038dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-159-03e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-159-039bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A062058-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALABApproved before 1982
A062058-002AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALABApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A062058-001AB
A062058-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062058-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062058-002AMOXICILLIN500MGCAPSULE / ORALABApproved before 1982bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A062058-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A062058-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062058-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062058-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062058-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062058-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062058-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062058-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062058-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062058-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062058-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062058-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062058-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062058-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062058-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062058-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062058-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062058-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062058-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062058-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062058-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062058-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062058-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062058-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062058-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062058-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062058-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062058-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062058-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062058-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062058-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062058-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062058-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062058-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062058-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062058-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062058-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062058-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062058-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062058-002AB1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-159-032026-01-06C16284748780-19d75b9d0-9fb5-f424-e053-dadaa90a57ceAMOXICILLAN 500 MG
51655-159-032020-01-31C16284748780-19d75b9d0-9fb5-f424-e053-dadaa90a57ceAMOXICILLAN 500 MG

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLAN TABLET [NORTHWIND PHARMACEUTICALS,LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLAN TABLET [NORTHWIND PHARMACEUTICALS,LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-159AMOXICILLAN TABLET [NORTHWIND PHARMACEUTICALS,LLC]1Legacy NDC20140731_49dd44b2-74fa-43e7-ac36-b0b84cdc17c9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINChartwell RX, LLC5002cce4-0abc-4446-888c-47396549d4da2025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062058
application number: ANDA062058
AmoxicillinAMOXICILLINChartwell Governmental & Specialty RX, LLCf9062321-ffb3-42e8-8f98-453cd30f52822025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062058
application number: ANDA062058