Amoxicillin

Product NDC
50090-4078
11-digit product format
500904078
Labeler code
50090
Product ID
50090-4078_347e34aa-8dc6-4351-93e8-e91300987233
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065119
Marketing category
ANDA
Marketing start
2003-02-26
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
400 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct50090-4078IInactivated by FDA2026-08-17
excluded packagepackage50090-407850090-4078-0IInactivated 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 · 30 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 packagepackage50090-4078-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4078-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4078-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4078-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4078-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4078-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4078-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4078-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4078-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4078-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4078-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4078-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4078-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4078-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4078-01332a3947898…d4bfe170f9cd…

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
A065119-001AMOXICILLINAMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04
A065119-002AMOXICILLINAMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065119-001AB
A065119-002AB

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 06:07:402026-07A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04caaa826d4ba7…
2026-08-18 06:07:402026-07A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065119-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2002-12-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065119-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALABRS2002-12-04bb7c543d1eb4…

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 06:07:402026-07A065119-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065119-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065119-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065119-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065119-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065119-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065119-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065119-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065119-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065119-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065119-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065119-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065119-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065119-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065119-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065119-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065119-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065119-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065119-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065119-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065119-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065119-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065119-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065119-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065119-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065119-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065119-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065119-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065119-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065119-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065119-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065119-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065119-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065119-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065119-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065119-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065119-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065119-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065119-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065119-002AB1bb7c543d1eb4…

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
50090-4078-0Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4078AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210417_19a5a6d9-8cd1-4013-96ea-e219d6a534ba.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMOXICILLINAMOXICILLINChartwell RX, LLCb07b5ac4-253e-4c83-91c3-3fdc46e91a0f2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065119
application number: ANDA065119
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.8dfbaa75-87ba-4a6b-a2db-176441a842af2026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065119
application number: ANDA065119
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.c84082fc-ea07-4e73-99c5-8356b957a1c52025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065119
application number: ANDA065119
AmoxicillinAMOXICILLINTeva Pharmaceuticals USA, Inc.4c0f348a-a65d-409c-8668-207c82a5e3cb2024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065119
application number: ANDA065119
AmoxicillinAMOXICILLINProficient Rx LP45a872b8-07b1-44fe-8b57-cc572d480e2e2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065119
application number: ANDA065119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN19a5a6d9-8cd1-4013-96ea-e219d6a534ba4
308189amoxicillin 80 MG/ML Oral SuspensionSCD19a5a6d9-8cd1-4013-96ea-e219d6a534ba4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY19a5a6d9-8cd1-4013-96ea-e219d6a534ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4078-05009040780075 mL in 1 BOTTLE (50090-4078-0) 75 ml2019-01-230000-00-00NoNoCurrent