Amoxicillin

Product NDC
67296-1126
Requested package NDC
67296-1126-2
11-digit product format
672961126
Labeler code
67296
Product ID
67296-1126_d60fdf62-9208-4fa8-e053-2995a90adb18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
875 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-112667296-1126-2IInactivated by FDA2026-08-11

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
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 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…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1126-12024-01-30C16284748780-11030e365-60c6-111a-e063-dadaa90a10e24ea4ab20-93f6-57c2-e054-00144ff88e88
67296-1126-22024-01-30C16284748780-11030e365-60c6-111a-e063-dadaa90a10e24ea4ab20-93f6-57c2-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1126-1Amoxicillin14 in 1 BOTTLETABLET, FILM COATED143
67296-1126-2Amoxicillin20 in 1 BOTTLETABLET, FILM COATED203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1126AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 2 package rows20220121_4ea4ab20-93f6-57c2-e054-00144ff88e88.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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINCoupler LLC5827b6de-6b48-d73a-e063-6394a90a4a722026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN4ea4ab20-93f6-57c2-e054-00144ff88e883
308194amoxicillin 875 MG Oral TabletSCD4ea4ab20-93f6-57c2-e054-00144ff88e883
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY4ea4ab20-93f6-57c2-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1126-26729611260220 TABLET, FILM COATED in 1 BOTTLE (67296-1126-2) 2005-11-090000-00-00NoNoCurrent