Amoxicillin

Product NDC
68071-2908
11-digit product format
680712908
Labeler code
68071
Product ID
68071-2908_f1740cdc-19eb-49bf-e053-2995a90acc70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA064076
Marketing category
ANDA
Marketing start
1994-09-30
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
2024-12-31
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 productproduct68071-2908IInactivated by FDA2026-08-03
excluded packagepackage68071-290868071-2908-3IInactivated 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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2908-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2908-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2908-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2908-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2908-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2908-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2908-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2908-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2908-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A064076-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALAB1994-09-30
A064076-002AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALAB1994-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A064076-001AB
A064076-002AB

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 UTC2026-02A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30782e0a99824c…

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 UTC2026-02A064076-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064076-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064076-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064076-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064076-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064076-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064076-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064076-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064076-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064076-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064076-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064076-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064076-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064076-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064076-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064076-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064076-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064076-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064076-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A064076-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064076-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064076-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064076-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064076-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064076-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064076-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064076-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064076-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064076-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064076-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064076-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064076-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064076-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064076-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064076-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064076-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064076-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064076-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064076-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A064076-002AB1782e0a99824c…

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
68071-2908-3Amoxicillin30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2908AMOXICILLIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20230105_f1740cd4-d0f4-6f4b-e053-2995a90aa398.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINREMEDYREPACK INC.102c62ca-da20-4866-84a8-e3513824af4a2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINNorthwind Health Company, LLC4ecefd37-9847-1d93-e063-6394a90a19f02026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINCoupler LLC52bd03c6-528a-c443-e063-6394a90aad392026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepackbe7d8459-b8e6-499a-ab87-99bd174925252026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINQPharma Incddd1307d-3216-0e59-e053-2995a90ad19d2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINCoupler LLC50fff2b8-8bf1-ff46-e063-6394a90a92132026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINREMEDYREPACK INC.82c0c5d1-df2d-4352-bd12-99f955af569e2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINREMEDYREPACK INC.bb95fd06-f200-4de3-bfae-84d642d8e0f32026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.76ba0f8d-4d1c-a5ff-e053-2a91aa0a75552024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.6e9bf369-2f96-c7ae-e053-2a91aa0a715f2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepack7b182161-128e-430c-98b2-592c242ba7112024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepack260a3a79-9dd6-4c4b-82ec-f8050346e8862024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepackaee851cf-428e-4d29-a281-078fe00c56b02024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepack9925773d-8ea1-4193-91e3-52cc1ce5ca672024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINSandoz Inc13bd4214-9b7f-425b-af5f-fc1ddc6782302024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepackc5d39ce2-8ae4-4bba-893f-a713afba18932023-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINAsclemed USA, Inc.f27237d7-123a-44ba-97df-b2446a94e3e52021-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINProficient Rx LP9528a356-4101-4be2-a7e2-b0659e169e1a2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSNf1740cd4-d0f4-6f4b-e053-2995a90aa3981
308182amoxicillin 250 MG Oral CapsuleSCDf1740cd4-d0f4-6f4b-e053-2995a90aa3981
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYf1740cd4-d0f4-6f4b-e053-2995a90aa3981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2908-36807129080330 CAPSULE in 1 BOTTLE (68071-2908-3) 30 capsule2022-01-040000-00-00NoNoCurrent