Amoxicillin

Product NDC
68071-1675
11-digit product format
680711675
Labeler code
68071
Product ID
68071-1675_2a31a975-72fc-2a16-e063-6394a90a8149
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065325
Marketing category
ANDA
Marketing start
2006-06-19
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

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-1675-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-1675-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-1675-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-1675-11332a3947898…d4bfe170f9cd…

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
A065325-001AMOXICILLINAMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19
A065325-002AMOXICILLINAMOXICILLIN200MG/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
A065325-001AB
A065325-002AB

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 UTC2026-02A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065325-002AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065325-001AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-06-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A065325-002AMOXICILLIN200MG/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 UTC2026-02A065325-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065325-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065325-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065325-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065325-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065325-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065325-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065325-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065325-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065325-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065325-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065325-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065325-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065325-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065325-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065325-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065325-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065325-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065325-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065325-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065325-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065325-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065325-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065325-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065325-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065325-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065325-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065325-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065325-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065325-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065325-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065325-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065325-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065325-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065325-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065325-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065325-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065325-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065325-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065325-002AB1782e0a99824c…

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
59a546ed-84b7-a54a-e053-2991aa0a3a0dAvailable 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#

Effective, Related label table
EffectiveRelated label
2024-07-15These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp
2023-01-30These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp
2021-02-11These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp
2021-01-29These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1675-1Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1675AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20241228_59a546ed-84b7-a54a-e053-2991aa0a3a0d.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.afef7c71-2d19-41ed-9213-b32ccc1bf1d32026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.c0e333d9-164d-4196-b5f5-929993d1c3c22026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.992d7829-34d1-4c88-8a5c-1a92d001d1942025-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxilAMOXICILLIN ORAL SUSPDirectRxec7dd735-dc92-3d29-e053-2a95a90af5492025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.59a546ed-84b7-a54a-e053-2991aa0a3a0d2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
ndc (product): 68071-1675
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8398f2c9-37ca-9b59-e053-2991aa0a2c112024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.d46f1091-33dc-4f8f-9c34-75dcfedb4b4c2024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxicillinAMOXICILLINA-S Medication Solutionscef5b1ae-8454-4e7a-8830-dd5d601c1d212023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxicillinAMOXICILLINA-S Medication Solutions156ef8e9-b6e4-4512-865f-7139c90c8f9b2023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxicillinAMOXICILLINA-S Medication Solutions77265bcd-c05d-443a-84c4-6e5ac75ee42c2023-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325
AmoxicillinAMOXICILLINProficient Rx LP756545f1-77af-49a0-a697-4cced31711d42022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065325
application number: ANDA065325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN59a546ed-84b7-a54a-e053-2991aa0a3a0d5
308189amoxicillin 80 MG/ML Oral SuspensionSCD59a546ed-84b7-a54a-e053-2991aa0a3a0d5
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY59a546ed-84b7-a54a-e053-2991aa0a3a0d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1675-168071167501100 mL in 1 BOTTLE (68071-1675-1) 100 ml2017-09-200000-00-00NoNoCurrent