AMOXICILLIN

Product NDC
64205-219
11-digit product format
642050219
Labeler code
64205
Product ID
64205-219_a4e7a41f-c95d-4726-9e57-0cf382ce4ddb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ReadyMeds
Application
NDA050754
Marketing category
NDA
Marketing start
1978-07-10
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
875 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64205-219IInactivated by FDA2026-10-05
excluded packagepackage64205-21964205-219-14IInactivated by FDA2026-10-05
excluded packagepackage64205-21964205-219-20IInactivated 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 · 66 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 packagepackage64205-219-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64205-219-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64205-219-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64205-219-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64205-219-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64205-219-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64205-219-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64205-219-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64205-219-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64205-219-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64205-219-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64205-219-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64205-219-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64205-219-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64205-219-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64205-219-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64205-219-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64205-219-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64205-219-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64205-219-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64205-219-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64205-219-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64205-219-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64205-219-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64205-219-208af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64205-219-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64205-219-20834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64205-219-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64205-219-201332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64205-219-141332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64205-219-20fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64205-219-14fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64205-219-2086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64205-219-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64205-219-20bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64205-219-14bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64205-219-208dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64205-219-148dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64205-219-20e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64205-219-14e2bbac7714bc…27bdfed8d636…

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
N050754-001AMOXILAMOXICILLIN875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10
N050754-002AMOXILAMOXICILLIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10

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 22:38:342026-08N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-1084e616aacf4f…
2026-08-18 06:07:402026-07N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1998-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050754-001AMOXIL875MGTABLET / ORALRLD1998-07-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050754-002AMOXIL500MGTABLET / ORALRLD1998-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050754-001AMOXIL875MGTABLET / ORALRLD1998-07-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050754-002AMOXIL500MGTABLET / ORALRLD1998-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050754-001AMOXIL875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1998-07-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050754-002AMOXIL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD1998-07-1074a2ff9319b5…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-219-14AMOXICILLIN14 in 1 BOTTLETABLET, FILM COATED143
64205-219-20AMOXICILLIN20 in 1 BOTTLETABLET, FILM COATED203

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [READYMEDS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-219AMOXICILLIN TABLET, FILM COATED [READYMEDS]3Legacy NDC, 2 package rows20140630_1ce3c575-6de7-4d93-8efc-fa1c75b7ecde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSN1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3
308194amoxicillin 875 MG Oral TabletPSN1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3
308192amoxicillin 500 MG Oral TabletSCD1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3
308194amoxicillin 875 MG Oral TabletSCD1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-219-146420502191414 in 1 BOTTLEHistorical
64205-219-206420502192020 in 1 BOTTLEHistorical