Amoxicillin

Product NDC
68071-2875
11-digit product format
680712875
Labeler code
68071
Product ID
68071-2875_ed20f445-e129-2dcc-e053-2995a90aa567
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204030
Marketing category
ANDA
Marketing start
2014-09-15
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2875IInactivated by FDA2026-08-17
excluded packagepackage68071-287568071-2875-1IInactivated by FDA2026-08-17

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 · 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 packagepackage68071-2875-1IInactivated 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 packagepackage68071-2875-1IInactivated 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 packagepackage68071-2875-1IInactivated 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 packagepackage68071-2875-1IInactivated 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 packagepackage68071-2875-1IInactivated 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 packagepackage68071-2875-1IInactivated 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 packagepackage68071-2875-1UExcluded 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 packagepackage68071-2875-1UExcluded 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 packagepackage68071-2875-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A204030-001AMOXICILLINAMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15
A204030-002AMOXICILLINAMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204030-001AB
A204030-002AB

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 06:07:402026-07A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204030-001AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2014-09-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204030-002AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2014-09-15bb7c543d1eb4…

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 06:07:402026-07A204030-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204030-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204030-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204030-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204030-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204030-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204030-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204030-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204030-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204030-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204030-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204030-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204030-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204030-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204030-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204030-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204030-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204030-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204030-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204030-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204030-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204030-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204030-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204030-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204030-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204030-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204030-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204030-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204030-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204030-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204030-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204030-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204030-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204030-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204030-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204030-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204030-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204030-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204030-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204030-002AB1bb7c543d1eb4…

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
68071-2875-1Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2875AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221111_ed20fac8-21e3-c8f6-e053-2a95a90a5d23.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
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.c19b533a-907a-6350-e053-2a95a90a12442026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204030
application number: ANDA204030
AmoxicillinAMOXICILLINProficient Rx LPc8e5ad7d-09b7-41d9-8cb0-467b3e8df74f2024-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204030
application number: ANDA204030
AmoxicillinAMOXICILLINAurobindo Pharma Limited234d0dfc-cb24-413f-b798-129c73eb848e2024-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204030
application number: ANDA204030
AmoxicillinAMOXICILLINA-S Medication Solutions14a5f8c2-fdaf-4ad4-982b-c5aa128e242d2024-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204030
application number: ANDA204030
AmoxicillinAMOXICILLINA-S Medication Solutions7db086c6-a56b-4848-9eec-abaaff9f5b6f2024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204030
application number: ANDA204030
AmoxicillinAMOXICILLINA-S Medication Solutionsa2a5bb34-671b-499c-b8b4-c40fb51af09a2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204030
application number: ANDA204030
AmoxicillinAMOXICILLINA-S Medication Solutionsefc66d77-1733-41e1-9aed-7c10a4b4ba962024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204030
application number: ANDA204030
AmoxicillinAMOXICILLINA-S Medication Solutions6a3d1af5-6e93-4f06-8d82-1c87290c46aa2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204030
application number: ANDA204030

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNed20fac8-21e3-c8f6-e053-2a95a90a5d231
239191amoxicillin 50 MG/ML Oral SuspensionSCDed20fac8-21e3-c8f6-e053-2a95a90a5d231
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYed20fac8-21e3-c8f6-e053-2a95a90a5d231
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYed20fac8-21e3-c8f6-e053-2a95a90a5d231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2875-168071287501100 mL in 1 BOTTLE (68071-2875-1) 100 ml2022-11-100000-00-00NoNoCurrent