Amoxicillin

Product NDC
68071-4944
11-digit product format
680714944
Labeler code
68071
Product ID
68071-4944_1b2e2026-ae73-e31c-e063-6294a90ab36d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA061926
Marketing category
ANDA
Marketing start
1990-09-30
Substance
AMOXICILLIN
Active strength
250 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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4944-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4944-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4944-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68071-4944-3fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68071-4944-386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68071-4944-3bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68071-4944-38dfbde2a14a4…c9ff85d89658…

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
A061926-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALABApproved before 1982
A061926-003AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A061926-001AB
A061926-003AB

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 06:07:402026-07A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982bb7c543d1eb4…

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 06:07:402026-07A061926-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A061926-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061926-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061926-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A061926-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061926-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061926-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A061926-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061926-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061926-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061926-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061926-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061926-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061926-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061926-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061926-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061926-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061926-003AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 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
308182Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c3ba9cf-9a28-3965-e053-2a95a90a38ceAvailable 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4944-3Amoxicillin3 in 1 BOTTLECAPSULE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4944AMOXICILLIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20240619_8c3ba9cf-9a28-3965-e053-2a95a90a38ce.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINChartwell Governmental & Specialty RX, LLC809393b7-6271-4715-ae84-13fd8f9017722026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AMOXICILLINAMOXICILLINChartwell RX, LLCb07b5ac4-253e-4c83-91c3-3fdc46e91a0f2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINQPharma, Inc60c788d1-6c91-4456-848a-893e649e90be2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINRedpharm Drug3d0025b4-b7bb-69db-e063-6294a90a0e702025-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.80a04b8a-110e-0aea-e053-2a91aa0ad0572025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8c3ba9cf-9a28-3965-e053-2a95a90a38ce2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
ndc (product): 68071-4944
AmoxicillinAMOXICILLINTeva Pharmaceuticals USA, Inc.4c0f348a-a65d-409c-8668-207c82a5e3cb2024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926
AmoxicillinAMOXICILLINAsclemed USA, Inc.be1d1a44-7ef3-445d-9970-494921de4c9d2023-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061926
application number: ANDA061926

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN8c3ba9cf-9a28-3965-e053-2a95a90a38ce2
308182amoxicillin 250 MG Oral CapsuleSCD8c3ba9cf-9a28-3965-e053-2a95a90a38ce2
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY8c3ba9cf-9a28-3965-e053-2a95a90a38ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-4944-3680714944033 CAPSULE in 1 BOTTLE (68071-4944-3) 3 capsule2019-06-26NoNoCurrent