Amoxicillin

Product NDC
68071-5096
Requested package NDC
68071-5096-3
11-digit product format
680715096
Labeler code
68071
Product ID
68071-5096_2425badb-e194-e9f8-e063-6294a90a7bf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
875 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 · 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
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-509668071-5096-3DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-509668071-5096-3DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…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
A065256-001AMOXICILLINAMOXICILLIN500MGTABLET / ORALAB2005-11-09
A065256-002AMOXICILLINAMOXICILLIN875MGTABLET / ORALAB2005-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065256-001AB
A065256-002AB

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 UTC2026-02A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09782e0a99824c…

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 UTC2026-02A065256-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065256-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065256-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065256-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065256-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065256-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065256-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065256-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065256-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065256-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065256-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065256-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065256-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065256-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065256-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065256-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065256-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065256-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 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
308194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
963986fc-0e59-21b0-e053-2a95a90a9531Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5096-2Amoxicillin20 in 1 BOTTLETABLET, FILM COATED206
68071-5096-3Amoxicillin30 in 1 BOTTLETABLET, FILM COATED306
68071-5096-7Amoxicillin14 in 1 BOTTLETABLET, FILM COATED146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5096AMOXICILLIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20241012_963986fc-0e59-21b0-e053-2a95a90a9531.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINREMEDYREPACK INC.a2c91cf0-a4e4-44c0-b712-bee63dd6c22b2026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINREMEDYREPACK INC.9618d038-e880-47f6-b8d7-bbf8ab35364d2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINREMEDYREPACK INC.f37eb415-77b2-41b0-8d20-64e821e4b05d2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINProficient Rx LP313ea909-5b1b-41ff-a0db-5aadc12e2e4f2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINCoupler LLC5037e2a5-52e9-caec-e063-6294a90ad8372026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINAmerican Health Packagingd339ea0f-8797-460f-a3b7-b8455c2503662026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.4b23e6f5-9287-4c01-b795-b8c5388330392026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.f1eee459-9021-b26e-e053-2995a90a72912026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINQPharma, Inc.2700df91-c5ef-4931-9ad7-a3c1c146ccac2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8e6f9df1-0754-69e4-e053-2a95a90acc492025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.3e4f0f03-438b-ddfb-e063-6294a90adb382025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.3880b9c2-62a5-0d23-e063-6394a90a12522025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINA-S Medication Solutionsb91f40dd-40db-473d-a399-166aeb1ce7e22025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINA-S Medication Solutionsaaf42367-153e-4525-af5f-f5f1c7d6c5592024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINBryant Ranch Prepackbef50f2a-78c6-4d0c-8ad9-cfa3c801629d2024-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.963986fc-0e59-21b0-e053-2a95a90a95312024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
ndc (package): 68071-5096-3
ndc (product): 68071-5096
ndc11 (package): 68071509603
AmoxicillinAMOXICILLINA-S Medication Solutionsc3d3f94f-e976-4625-9667-3d716932f2fa2024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.20eb4ade-f3b8-db66-e063-6294a90ae8462024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINAsclemed USA, Inc.a18751fa-6202-4ae2-950a-a3f1dc9a8afd2024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINRising Pharma Holdings, Inc.bb7733f8-6aad-4273-84a0-ef472630203f2024-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN963986fc-0e59-21b0-e053-2a95a90a95316
308194amoxicillin 875 MG Oral TabletSCD963986fc-0e59-21b0-e053-2a95a90a95316
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY963986fc-0e59-21b0-e053-2a95a90a95316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-5096-36807150960330 TABLET, FILM COATED in 1 BOTTLE (68071-5096-3) 2019-10-31NoNoCurrent