Amoxicillin

Product NDC
33261-144
11-digit product format
332610144
Labeler code
33261
Product ID
33261-144_d4fa5d57-edb5-4dc5-94a0-5cd9bddc9dcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-09-11
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-144IInactivated by FDA2026-08-03
excluded packagepackage33261-14433261-144-30IInactivated by FDA2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-144-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-144-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-144-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-144-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-144-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-144-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-144-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-144-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-144-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-144-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-144-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-144-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-144-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-144-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-144-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-144-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-144-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-144-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-144-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-144-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-144-309bebd1f3094a…5416666fcb17…

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
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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-03-09 01:35 UTC2022-03A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-03-09 01:35 UTC2022-03A065271-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065271-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065271-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065271-002AB1782e0a99824c…

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
33261-144-30Amoxicillin30 in 1 BOTTLECAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-144AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20120912_a8b3caf1-31c3-4a78-9e74-7a1e3968a0ec.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 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4a402dba-c255-5db8-e054-00144ff8d46c2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8cb987bf-d45a-c15a-e053-2995a90aad462026-07-21Warnings, 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
AmoxicillinAMOXICILLINREMEDYREPACK INC.3a4afd36-dffa-44a1-9d09-e93cf66053bf2026-06-09Warnings, 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
AmoxicillinAMOXICILLINREMEDYREPACK INC.afb4149a-0714-4a85-b9e8-2379a8e6a3022026-04-08Warnings, 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
AmoxicillinAMOXICILLINQPharma Inc2772a745-1276-405b-b229-95edf5534b2a2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.071086f5-e4ed-b1d9-e063-6294a90ad3042025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINBryant Ranch Prepackbbaeb509-ad04-4668-a1db-4358038893f22025-10-23Warnings, 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 CapsulePSNa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin 500 MG Oral CapsulePSNa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308182amoxicillin 250 MG Oral CapsuleSCDa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin 500 MG Oral CapsuleSCDa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-144-303326101443030 in 1 BOTTLEHistorical