FDA.reportPublic FDA data

Amoxicillin

Product NDC
67296-0002
11-digit product format
672960002
Labeler code
67296
Product ID
67296-0002_3d018e0f-e47d-7472-e063-6294a90a2fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug
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
ndc (product): 67296-0002
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
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
3d0025b4-b7bb-69db-e063-6294a90a0e70Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0002-1Amoxicillin20 in 1 BOTTLECAPSULE201
67296-0002-2Amoxicillin30 in 1 BOTTLECAPSULE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN3d0025b4-b7bb-69db-e063-6294a90a0e701
308182amoxicillin 250 MG Oral CapsuleSCD3d0025b4-b7bb-69db-e063-6294a90a0e701
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY3d0025b4-b7bb-69db-e063-6294a90a0e701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-0002-16729600020120 CAPSULE in 1 BOTTLE (67296-0002-1) 20 capsule1990-09-30NoNoCurrent
67296-0002-26729600020230 CAPSULE in 1 BOTTLE (67296-0002-2) 30 capsule1990-09-30NoNoCurrent