FDA.reportPublic FDA data

Amoxicillin

Product NDC
68071-4944
Requested package NDC
68071-4944-3
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

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A061926-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A061926-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 68071-4944-3
ndc (product): 68071-4944
ndc11 (package): 68071494403
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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4944-32024-06-18C16284748780-1ba0f9c33-12f0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE) safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE). AMOXICILLIN capsules, AMOXICILLIN for oral suspension, and AMOXICILLIN tablets (chewable) for oral use Initial U.S. Approval: 1974
68071-4944-32021-01-29C16284748780-1ba0f9c33-12f0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE) safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE). AMOXICILLIN capsules, AMOXICILLIN for oral suspension, and AMOXICILLIN tablets (chewable) for oral use Initial U.S. Approval: 1974

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

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