Amoxicillin

Product NDC
50090-0302
Requested package NDC
50090-0302-5
11-digit product format
500900302
Labeler code
50090
Product ID
50090-0302_c5cd7329-898f-49e0-9631-f49f4628ff04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065291
Marketing category
ANDA
Marketing start
2007-03-01
Substance
AMOXICILLIN
Active strength
500 mg/1
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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A065291-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALAB2007-02-05
A065291-002AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALAB2007-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065291-001AB
A065291-002AB

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 06:07:402026-07A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05bb7c543d1eb4…

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 06:07:402026-07A065291-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065291-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065291-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065291-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065291-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065291-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065291-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065291-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065291-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065291-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065291-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065291-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065291-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065291-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065291-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065291-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065291-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065291-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065291-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065291-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065291-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065291-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065291-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065291-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065291-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065291-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065291-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065291-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065291-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065291-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065291-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065291-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065291-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065291-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065291-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065291-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065291-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065291-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065291-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065291-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1

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
308191Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
364f969d-3037-4dff-b04b-304bca27442eAvailable 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
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0302-42023-03-03These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0302-52023-03-03These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0302-62023-03-03These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0302-72023-03-03These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0302-42020-01-31These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0302-52020-01-31These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0302-62020-01-31These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0302-72020-01-31These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0302-0Amoxicillin12 in 1 BOTTLECAPSULE1227
50090-0302-4Amoxicillin56 in 1 BOTTLECAPSULE5627
50090-0302-5Amoxicillin4 in 1 BOTTLECAPSULE427
50090-0302-6Amoxicillin20 in 1 BOTTLECAPSULE2027
50090-0302-7Amoxicillin100 in 1 BOTTLECAPSULE10027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0302-4EA - Each50090-0302f140da4f-1a46-49f3-a07d-3a67636b121912018-08-13
50090-0302-5EA - Each50090-0302d5d0d67d-7117-49c9-b448-8eaf1c19db4412018-08-13
50090-0302-6EA - Each50090-03028600a595-93dc-44f2-ba22-07e2c55ba6cf12018-08-13
50090-0302-7EA - Each50090-03020b51bb78-83d8-41ff-8c37-191054eae64512018-08-13

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.18a4f555-a537-4c40-9bb2-dc3bd782fa272026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.96057ce7-9516-4239-9974-5e9691b44c9b2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.4fb7837e-964c-4d38-a3a5-b384b1bd6e082026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.039d2677-b04f-436c-e063-6294a90ac5192025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINREMEDYREPACK INC.b6ea2f81-aee6-4c88-b681-50eb28e80a862025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINA-S Medication Solutionsfd071263-b750-4831-9fc5-de112a5f685b2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINA-S Medication Solutionsb988349d-2198-4dbb-a231-9ba37262ce282025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINA-S Medication Solutions364f969d-3037-4dff-b04b-304bca27442e2025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
ndc (package): 50090-0302-5
ndc (product): 50090-0302
ndc11 (package): 50090030205
AmoxicillinAMOXICILLINA-S Medication Solutions521f7a05-4e6d-447f-b38e-00c4d623703b2025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN364f969d-3037-4dff-b04b-304bca27442e27
308191amoxicillin 500 MG Oral CapsuleSCD364f969d-3037-4dff-b04b-304bca27442e27
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY364f969d-3037-4dff-b04b-304bca27442e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0302-5500900302054 CAPSULE in 1 BOTTLE (50090-0302-5) 4 capsule2014-11-28NoNoCurrent