Amoxicillin

Product NDC
55289-020
Requested package NDC
55289-020-06
11-digit product format
552890020
Labeler code
55289
Product ID
55289-020_e6e997ff-d352-79a0-e053-2a95a90a1ba7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA061926
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55289-02055289-020-06DDiscontinued by firm2026-08-17

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-02055289-020-06DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
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.

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 06:07:402026-07A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061926-001AMOXICILLIN250MGCAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061926-003AMOXICILLIN500MGCAPSULE / ORALABRS, Approved before 1982bb7c543d1eb4…

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 06:07:402026-07A061926-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A061926-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061926-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061926-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061926-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A061926-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061926-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061926-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061926-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061926-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061926-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061926-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061926-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061926-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A061926-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061926-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061926-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061926-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061926-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061926-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061926-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061926-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061926-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061926-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061926-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061926-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061926-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061926-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061926-003AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-020-04EA - Each55289-020e43ad63e-5965-4496-bf92-88d738abd64112012-07-24
55289-020-06EA - Each55289-020951f2b6b-0f72-4479-8a8c-b88c14fa6b4812012-07-24
55289-020-09EA - Each55289-0204885c899-6ee3-4aa3-a54f-fddd62297c4c12012-07-24
55289-020-14EA - Each55289-0201c053078-f89e-4cb7-b02e-63019aa6d19012012-07-24
55289-020-15EA - Each55289-020c73f6a18-3aca-46e6-b59d-3fe46c49818b12012-07-24
55289-020-21EA - Each55289-0200d93c225-e8cc-42b0-b193-3481441f3af512012-07-24
55289-020-24EA - Each55289-02046a283e0-3b4d-4a9d-81d8-5b8ff88f5a2512012-07-24
55289-020-28EA - Each55289-02093fbc4c7-944c-40b4-a32e-8665def0558112012-07-24
55289-020-30EA - Each55289-02022b380f5-a28c-493f-8bdb-7c5c8cdc18c712012-07-24
55289-020-40EA - Each55289-0200a416e16-1609-416c-9138-b1dff044fb2312012-07-24
55289-020-42EA - Each55289-0204f414cac-b3f2-4b2a-ae25-0957b64b5fdd12013-04-01
55289-020-50EA - Each55289-0208f4687b8-e2e7-4ff3-9eb0-1bfdd8d515eb12012-07-24
55289-020-56EA - Each55289-0202a0c8279-e586-49b6-bc77-7c7b82ffc16012012-07-24
55289-020-60EA - Each55289-0205c737d47-2804-4eef-860a-68d6e50ee6e112012-07-24
55289-020-63EA - Each55289-0209d0fed61-e08e-4105-a09d-28d3cdcc6dd012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-020AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]29Legacy NDC20250104_610ead3d-a415-4762-8c3c-91c87665f138.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 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-020-06552890020066 CAPSULE in 1 BOTTLE, PLASTIC (55289-020-06) 6 capsule2013-03-250000-00-00NoNoCurrent