Amoxicillin

Product NDC
60687-798
11-digit product format
606870798
Labeler code
60687
Product ID
60687-798_4ee4fb77-9fd6-ea5e-e063-6394a90a0d9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065256
Marketing category
ANDA
Marketing start
2025-03-25
Marketing end
2026-12-31
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Current FDA listing
Yes

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
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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09caaa826d4ba7…
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…

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 06:07:402026-07A065256-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065256-002AB1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 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
308192Internal RxNorm lookup
308194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d339ea0f-8797-460f-a3b7-b8455c250366Available 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-798-25Amoxicillin30 in 1 CARTONTABLET, FILM COATED304
60687-798-95Amoxicillin1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-798-25EA - Each60687-79883301110-b311-4b10-a115-f0f0036a982412025-03-04
60687-798-95EA - Each60687-79840d799f1-3735-4e9a-9a3a-9e008817c04612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-798AMOXICILLIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20250221_d339ea0f-8797-460f-a3b7-b8455c250366.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
ndc (product): 60687-798
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
308192amoxicillin 500 MG Oral TabletPSNd339ea0f-8797-460f-a3b7-b8455c2503664
308194amoxicillin 875 MG Oral TabletPSNd339ea0f-8797-460f-a3b7-b8455c2503664
308192amoxicillin 500 MG Oral TabletSCDd339ea0f-8797-460f-a3b7-b8455c2503664
308194amoxicillin 875 MG Oral TabletSCDd339ea0f-8797-460f-a3b7-b8455c2503664
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYd339ea0f-8797-460f-a3b7-b8455c2503664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-798-256068707982530 BLISTER PACK in 1 CARTON (60687-798-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-798-95) 30 blister pack2025-03-252026-12-31NoNoHistorical
60687-798-95606870798951 in 1 BLISTER PACKHistorical