Amoxicillin

Product NDC
50090-5215
11-digit product format
500905215
Labeler code
50090
Product ID
50090-5215_a2a36134-64a4-443b-a743-6359695e907a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065378
Marketing category
ANDA
Marketing start
2007-03-26
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
200 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct50090-5215IInactivated by FDA2026-08-17
excluded packagepackage50090-521550090-5215-0IInactivated 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 packagepackage50090-5215-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5215-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-5215-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-5215-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-5215-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-5215-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-5215-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-5215-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-5215-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-5215-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-5215-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-5215-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-5215-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-5215-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-5215-01332a3947898…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
A065378-001AMOXICILLINAMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26
A065378-002AMOXICILLINAMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065378-001AB
A065378-002AB

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 06:07:402026-07A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065378-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2007-03-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065378-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2007-03-26bb7c543d1eb4…

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 06:07:402026-07A065378-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065378-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065378-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065378-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065378-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065378-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065378-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065378-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065378-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065378-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065378-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065378-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065378-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065378-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065378-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065378-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065378-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065378-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065378-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065378-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065378-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065378-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065378-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065378-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065378-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065378-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065378-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065378-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065378-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065378-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065378-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065378-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065378-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065378-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065378-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065378-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065378-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065378-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065378-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065378-002AB1bb7c543d1eb4…

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
50090-5215-0Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5215AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20201009_d6456a2c-1988-4c96-a6fe-3fa157a2cea8.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINHAWAII REPACK, INC.669a243e-249d-4ccb-9693-66de073e53bb2026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065378
application number: ANDA065378
AmoxicillinAMOXICILLINREMEDYREPACK INC.81fe142e-a163-4632-93fb-7cd8d80c50bd2025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065378
application number: ANDA065378
AmoxicillinAMOXICILLINAsclemed USA, Inc.830bb8fb-3743-463a-9317-3f83e3e105ac2024-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065378
application number: ANDA065378
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.997650f9-7eff-64de-e053-2995a90a617b2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065378
application number: ANDA065378
AmoxicillinAMOXICILLINSandoz Inc13bd4214-9b7f-425b-af5f-fc1ddc6782302024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065378
application number: ANDA065378
AmoxicillinAMOXICILLINProficient Rx LPead1e453-af08-4a3b-8379-aa182dff514b2020-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065378
application number: ANDA065378

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSNd6456a2c-1988-4c96-a6fe-3fa157a2cea81
313850amoxicillin 40 MG/ML Oral SuspensionSCDd6456a2c-1988-4c96-a6fe-3fa157a2cea81
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSYd6456a2c-1988-4c96-a6fe-3fa157a2cea81
313850amoxicillin 200 MG per 5 ML Oral SuspensionSYd6456a2c-1988-4c96-a6fe-3fa157a2cea81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5215-050090521500100 mL in 1 BOTTLE (50090-5215-0) 100 ml2020-10-060000-00-00NoNoCurrent