Amoxicillin

Product NDC
50090-0411
11-digit product format
500900411
Labeler code
50090
Product ID
50090-0411_44ec7cdd-8503-4c59-8df8-9855651a5997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065322
Marketing category
ANDA
Marketing start
2006-06-19
Substance
AMOXICILLIN
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0411-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0411-0557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065322-001AMOXICILLINAMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19
A065322-002AMOXICILLINAMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065322-001AB
A065322-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065322-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065322-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065322-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065322-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065322-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065322-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065322-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065322-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065322-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065322-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065322-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065322-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065322-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065322-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065322-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065322-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065322-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065322-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
804826J2HUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
239191Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b5acc3f-c474-4b16-9d66-8048abb3b22dAvailable on FDA.report

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
50090-0411-0Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION809

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0411-0ML - Milliliter50090-04113062970c-b1aa-4698-b447-a6f5b41811ef12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0411AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20241105_0b5acc3f-c474-4b16-9d66-8048abb3b22d.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINA-S Medication Solutions60c7ae87-9631-4b29-9ca4-82fb3bafcab82026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.bd46de4c-4571-ba9a-e053-2a95a90a792d2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutions8bce45db-dea7-4090-9d64-8b11b08d963e2026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.0ce05282-995c-461e-b807-facb1fcbb4052026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.9cad7ff5-5151-47d9-bc66-2ded25deefc22025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.54c1d2a4-fe96-6efb-e054-00144ff88e882025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutions5b2a2e62-6fd2-4ab1-b936-8702e68233fa2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf2024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5c60cb1c-3baf-3af2-e053-2a91aa0ae2082024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutions0b5acc3f-c474-4b16-9d66-8048abb3b22d2024-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 50090-0411
AmoxicillinAMOXICILLINNuCare Pharmaceuticals Inc.2177c68d-2884-ce70-e063-6294a90aa2672024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINProficient Rx LP6a9cfa97-3715-4b75-a1e3-932a34a942d42024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.077f4a65-3cfb-4cb1-99f2-e27ffc5939c02024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutionsca2886d0-7be7-4d41-bad5-df3ad44e0e7e2023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutions6c7bccff-00bf-46b0-a9ee-eb27d38d73772023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINProficient Rx LP9cac2bf2-fb48-4e83-b953-61c4d55f7e192022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin 50 MG/ML Oral SuspensionSCD0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY0b5acc3f-c474-4b16-9d66-8048abb3b22d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0411-05009004110080 mL in 1 BOTTLE (50090-0411-0) 80 ml2016-06-290000-00-00NoNoCurrent