Amoxicillin

Product NDC
60687-776
11-digit product format
606870776
Labeler code
60687
Product ID
60687-776_2f75b1e8-87b4-bd7d-e063-6294a90a0587
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065271
Marketing category
ANDA
Marketing start
2025-02-27
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 43.

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
A065271-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALAB2005-11-09
A065271-002AMOXICILLINAMOXICILLIN500MGCAPSULE / 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
A065271-001AB
A065271-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0974a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065271-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065271-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A065271-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065271-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065271-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065271-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065271-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065271-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065271-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065271-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065271-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065271-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065271-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065271-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065271-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065271-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065271-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065271-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308182Internal RxNorm lookup
308191Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ecb439f7-434a-4e4c-b899-943d83346f09Available 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
60687-776-01Amoxicillin100 in 1 CARTONCAPSULE1003
60687-776-11Amoxicillin1 in 1 BLISTER PACKCAPSULE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-776-01EA - Each60687-776311c935b-5be6-44a7-bd9a-8361ab301fb912025-03-04
60687-776-11EA - Each60687-7767a4074e5-711c-4751-9016-06cf3716f5aa12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-776AMOXICILLIN CAPSULE [AMERICAN HEALTH PACKAGING]3Current NDC, 2 package rows20250305_ecb439f7-434a-4e4c-b899-943d83346f09.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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINSportpharm LLCc4d4aeca-f63c-4548-a9b7-7f627e8fd45c2026-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINREMEDYREPACK INC.3a4afd36-dffa-44a1-9d09-e93cf66053bf2026-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINREMEDYREPACK INC.afb4149a-0714-4a85-b9e8-2379a8e6a3022026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8cb987bf-d45a-c15a-e053-2995a90aad462026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINRedpharm Drug57f5652d-ee50-eb7e-e063-6394a90a7b662026-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINRedpharm Drug57e56202-950b-10f6-e063-6394a90a49122026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4a402dba-c255-5db8-e054-00144ff8d46c2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINHAWAII REPACK, INC.bf130964-8386-4ab7-8d3b-fb0174670afc2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNorthwind Health Company, LLC1d0d8bc4-137e-ef10-e063-6294a90acf622026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINREMEDYREPACK INC.53548597-347b-42a9-916c-e88cd27b8dcd2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINProficient Rx LPef03286b-4ba7-4952-9ab1-90cacf3005042026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5155ca5d-fe58-42b4-e063-6394a90ab1352026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINCoupler LLC5020950a-b248-a463-e063-6294a90ae57f2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINSportpharm LLC9bb2856b-feef-4063-befc-2dd9175028982026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINPreferred Phamraceuticals Inc.47424822-14a1-48e0-a62d-df34fe6857262026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.d6a33b28-f520-4a4c-b553-0ebd005583452026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.800f5fac-f2af-358f-e053-2a91aa0ad6a62026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINSportpharm LLCd55dd9d9-e901-47b6-b496-5f2749726a2e2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
Amoxicillin 500 mgAMOXICILLINHealth Department, Oklahoma Statef049551b-4708-eb13-e053-2a95a90afd1f2025-12-13Exact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINAsclemed USA, Inc.32b224c2-1354-4b58-b082-b93330e6962b2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSNecb439f7-434a-4e4c-b899-943d83346f093
308191amoxicillin 500 MG Oral CapsulePSNecb439f7-434a-4e4c-b899-943d83346f093
308182amoxicillin 250 MG Oral CapsuleSCDecb439f7-434a-4e4c-b899-943d83346f093
308191amoxicillin 500 MG Oral CapsuleSCDecb439f7-434a-4e4c-b899-943d83346f093
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYecb439f7-434a-4e4c-b899-943d83346f093
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYecb439f7-434a-4e4c-b899-943d83346f093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-776-0160687077601100 BLISTER PACK in 1 CARTON (60687-776-01) / 1 CAPSULE in 1 BLISTER PACK (60687-776-11) 100 blister pack2025-02-27NoNoCurrent
60687-776-11606870776111 in 1 BLISTER PACKHistorical