Amoxicillin

Product NDC
45865-594
11-digit product format
458650594
Labeler code
45865
Product ID
45865-594_9adc29d7-203d-24be-e053-2995a90a9c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA065228
Marketing category
ANDA
Marketing start
2005-07-13
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
875 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct45865-594IInactivated by FDA2026-08-17
excluded packagepackage45865-59445865-594-20IInactivated by FDA2026-08-17

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-594-20IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-594-20IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-594-20IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-594-20IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-594-20IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-594-20IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-594-20IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-594-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-594-20IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45865-594-20IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45865-594-20IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45865-594-20IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage45865-594-20IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage45865-594-20IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage45865-594-20IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductEExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage45865-594-20EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…

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
A065228-001AMOXICILLINAMOXICILLIN500MGTABLET / ORALAB2005-07-13
A065228-002AMOXICILLINAMOXICILLIN875MGTABLET / ORALAB2005-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065228-001AB
A065228-002AB

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 06:07:402026-07A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065228-001AMOXICILLIN500MGTABLET / ORALAB2005-07-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065228-002AMOXICILLIN875MGTABLET / ORALAB2005-07-13bb7c543d1eb4…

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 06:07:402026-07A065228-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065228-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065228-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065228-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065228-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065228-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065228-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065228-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065228-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065228-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065228-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065228-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065228-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065228-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065228-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065228-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065228-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065228-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065228-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065228-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065228-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065228-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065228-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065228-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065228-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065228-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065228-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065228-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065228-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065228-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065228-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065228-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065228-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065228-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065228-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065228-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065228-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065228-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065228-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065228-002AB1bb7c543d1eb4…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-594-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-594AMOXICILLIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191230_9adc29c6-79e0-3ede-e053-2a95a90a6721.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.ad804b34-169c-44bf-a469-f1149433d96b2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065228
application number: ANDA065228
AmoxicillinAMOXICILLINDirect_Rxf98c49a3-e6bb-7fc7-e053-6394a90a90622025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065228
application number: ANDA065228
AmoxicillinAMOXICILLINSandoz Inc13bd4214-9b7f-425b-af5f-fc1ddc6782302024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065228
application number: ANDA065228
AmoxicillinAMOXICILLINProficient Rx LP7974a666-6d1d-446b-8ea5-f7145dc663582020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065228
application number: ANDA065228

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN9adc29c6-79e0-3ede-e053-2a95a90a67211
308194amoxicillin 875 MG Oral TabletSCD9adc29c6-79e0-3ede-e053-2a95a90a67211
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY9adc29c6-79e0-3ede-e053-2a95a90a67211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-594-204586505942020 TABLET, FILM COATED in 1 BOTTLE (45865-594-20) 2018-12-120000-00-00NoNoCurrent