Amoxicillin

Product NDC
63187-262
Requested package NDC
63187-262-00
11-digit product format
631870262
Labeler code
63187
Product ID
63187-262_e6603270-d47e-47fc-bea9-0c1cea9f70aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065334
Marketing category
ANDA
Marketing start
2006-12-28
Substance
AMOXICILLIN
Active strength
400 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A065334-001AMOXICILLINAMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28
A065334-002AMOXICILLINAMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065334-001AB
A065334-002AB

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 UTC2026-02A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28782e0a99824c…

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 UTC2026-02A065334-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065334-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065334-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065334-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065334-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065334-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065334-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065334-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065334-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065334-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065334-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065334-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065334-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065334-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065334-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065334-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065334-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065334-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN400 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
308189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcdaba34-373f-4d4e-8203-76f02e3bb00aAvailable 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
63187-262-00Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1007
63187-262-50Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-262-00ML - Milliliter63187-2622ea420a0-1c18-4c90-bce3-2c6c4f925ad212024-04-05
63187-262-50ML - Milliliter63187-26294a8096a-0932-47b0-8ddf-870702346c5b12024-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-262AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]7Current NDC, Legacy NDC, 2 package rows20240113_fcdaba34-373f-4d4e-8203-76f02e3bb00a.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.573fcf4a-2b87-45d9-ac73-e1dec4fbc28b2026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINREMEDYREPACK INC.2732a8c7-9e4b-43c9-9712-df4b237ab69c2025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AMOXICILLINAMOXICILLINDirectRxcedde8f5-aadd-53de-e053-2995a90aab162025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINRising Pharma Holdings, Inc.554239db-69fe-405a-910a-d9f9e3f8b6ed2024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.97a657a3-8238-f5f1-e053-2a95a90a7a7a2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINAurobindo Pharma Limited3cacd754-73f4-496e-a529-9ca39fa6692d2024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINA-S Medication Solutionsd5ecb620-5267-4dcf-be81-64c7766516f52024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINA-S Medication Solutions3d8a700b-b23b-459a-a19a-213dd39b6a3a2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINA-S Medication Solutions1dc5cc5a-59ba-4bc9-b581-cb7b70ce26522024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AMOXICILLINAMOXICILLINDIRECT RX0173e9de-a995-4386-bb65-8fc2bbf347f92024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINProficient Rx LPfcdaba34-373f-4d4e-8203-76f02e3bb00a2024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (package): 63187-262-00
ndc (product): 63187-262
ndc11 (package): 63187026200
AmoxicillinAMOXICILLINProficient Rx LPd5eba477-e255-4d97-9e16-30543c2986802023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINProficient Rx LPe40f3e20-facf-46f4-89c7-3593bc27d0fc2021-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNfcdaba34-373f-4d4e-8203-76f02e3bb00a7
308189amoxicillin 80 MG/ML Oral SuspensionSCDfcdaba34-373f-4d4e-8203-76f02e3bb00a7
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYfcdaba34-373f-4d4e-8203-76f02e3bb00a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-262-0063187026200100 mL in 1 BOTTLE (63187-262-00) 100 ml2015-02-020000-00-00NoNoCurrent