Amoxicillin

Product NDC
63187-029
11-digit product format
631870029
Labeler code
63187
Product ID
63187-029_e61645ee-b492-46b5-bb37-8df0e39e20d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct63187-029EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63187-02963187-029-15EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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
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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19caaa826d4ba7…
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…

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 06:07:402026-07A065322-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065322-002AB1caaa826d4ba7…
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…

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
9cac2bf2-fb48-4e83-b953-61c4d55f7e19Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-029-15Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-029AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]4Current NDC, Legacy NDC, 1 package rows20221201_9cac2bf2-fb48-4e83-b953-61c4d55f7e19.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
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
ndc (product): 63187-029

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin 50 MG/ML Oral SuspensionSCD9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY9cac2bf2-fb48-4e83-b953-61c4d55f7e194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-029-1563187002915150 mL in 1 BOTTLE (63187-029-15) 150 ml2014-05-010000-00-00NoNoCurrent