Amoxicillin

Product NDC
0143-9889
11-digit product format
001439889
Labeler code
0143
Product ID
0143-9889_c2fa2c99-c735-4834-a8a5-04a30da8a002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065322
Marketing category
ANDA
Marketing start
2006-06-19
Substance
AMOXICILLIN
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0143-9889DDiscontinued by firm2026-08-17
excluded packagepackage0143-98890143-9889-01DDiscontinued by firm2026-08-17
excluded packagepackage0143-98890143-9889-15DDiscontinued by firm2026-08-17
excluded packagepackage0143-98890143-9889-80DDiscontinued 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 · 48 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 packagepackage0143-9889-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-9889-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-9889-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-9889-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-9889-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-9889-80f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-9889-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-9889-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-9889-802ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-9889-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-9889-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-9889-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-9889-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-9889-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-9889-80cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-9889-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-9889-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-9889-80cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-9889-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-9889-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-9889-80302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-9889-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-9889-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-9889-80ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-9889-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-9889-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-9889-800efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-9889-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-9889-15ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-9889-80ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-9889-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-9889-15367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-9889-80367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-9889-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-9889-15557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-9889-80557ba5c1ecfa…9c80585c8c6e…

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
A065322-001AMOXICILLINAMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19
A065322-002AMOXICILLINAMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065322-001AB
A065322-002AB

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 06:07:402026-07A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19caaa826d4ba7…
2026-08-18 06:07:402026-07A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19bb7c543d1eb4…

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 06:07:402026-07A065322-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065322-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065322-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065322-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065322-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065322-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065322-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065322-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065322-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065322-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065322-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065322-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065322-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065322-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065322-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065322-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065322-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065322-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 mg/5mL

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
239191Internal RxNorm lookup
313797Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
077f4a65-3cfb-4cb1-99f2-e27ffc5939c0Available 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
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9889-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003
0143-9889-15Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1503
0143-9889-80Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9889-01ML - Milliliter0143-98894a991313-40d8-494c-9f55-e410b843b4ae12012-07-24
0143-9889-15ML - Milliliter0143-98892dc5407e-6d9f-4e5a-be42-2dc4ea9847f212013-05-02
0143-9889-80ML - Milliliter0143-9889a8c22faa-3084-49d6-a5d9-b9912fb43ee312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9889AMOXICILLIN POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 3 package rows20240712_077f4a65-3cfb-4cb1-99f2-e27ffc5939c0.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINA-S Medication Solutions60c7ae87-9631-4b29-9ca4-82fb3bafcab82026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.bd46de4c-4571-ba9a-e053-2a95a90a792d2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutions8bce45db-dea7-4090-9d64-8b11b08d963e2026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.0ce05282-995c-461e-b807-facb1fcbb4052026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.9cad7ff5-5151-47d9-bc66-2ded25deefc22025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.54c1d2a4-fe96-6efb-e054-00144ff88e882025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutions5b2a2e62-6fd2-4ab1-b936-8702e68233fa2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf2024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5c60cb1c-3baf-3af2-e053-2a91aa0ae2082024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutions0b5acc3f-c474-4b16-9d66-8048abb3b22d2024-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals Inc.2177c68d-2884-ce70-e063-6294a90aa2672024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINProficient Rx LP6a9cfa97-3715-4b75-a1e3-932a34a942d42024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.077f4a65-3cfb-4cb1-99f2-e27ffc5939c02024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 0143-9889
AmoxicillinAMOXICILLINA-S Medication Solutionsca2886d0-7be7-4d41-bad5-df3ad44e0e7e2023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINA-S Medication Solutions6c7bccff-00bf-46b0-a9ee-eb27d38d73772023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINProficient Rx LP9cac2bf2-fb48-4e83-b953-61c4d55f7e192022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN6c7bccff-00bf-46b0-a9ee-eb27d38d737716
239191amoxicillin 50 MG/ML Oral SuspensionSCD6c7bccff-00bf-46b0-a9ee-eb27d38d737716
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY6c7bccff-00bf-46b0-a9ee-eb27d38d737716
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY6c7bccff-00bf-46b0-a9ee-eb27d38d737716
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNca2886d0-7be7-4d41-bad5-df3ad44e0e7e13
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN8bce45db-dea7-4090-9d64-8b11b08d963e13
239191amoxicillin 50 MG/ML Oral SuspensionSCDca2886d0-7be7-4d41-bad5-df3ad44e0e7e13
239191amoxicillin 50 MG/ML Oral SuspensionSCD8bce45db-dea7-4090-9d64-8b11b08d963e13
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYca2886d0-7be7-4d41-bad5-df3ad44e0e7e13
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY8bce45db-dea7-4090-9d64-8b11b08d963e13
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYca2886d0-7be7-4d41-bad5-df3ad44e0e7e13
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY8bce45db-dea7-4090-9d64-8b11b08d963e13
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin 50 MG/ML Oral SuspensionSCD0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN54c1d2a4-fe96-6efb-e054-00144ff88e886
239191amoxicillin 50 MG/ML Oral SuspensionSCD54c1d2a4-fe96-6efb-e054-00144ff88e886
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY54c1d2a4-fe96-6efb-e054-00144ff88e886
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY54c1d2a4-fe96-6efb-e054-00144ff88e886
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN4b359b26-8682-46fa-90a1-6270502ba9904
239191amoxicillin 50 MG/ML Oral SuspensionSCD9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin 50 MG/ML Oral SuspensionSCD4b359b26-8682-46fa-90a1-6270502ba9904
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY4b359b26-8682-46fa-90a1-6270502ba9904
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY4b359b26-8682-46fa-90a1-6270502ba9904
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY9cac2bf2-fb48-4e83-b953-61c4d55f7e194
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN0ce05282-995c-461e-b807-facb1fcbb4053
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNbd46de4c-4571-ba9a-e053-2a95a90a792d3
313797amoxicillin 25 MG/ML Oral SuspensionSCD077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 50 MG/ML Oral SuspensionSCD8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin 50 MG/ML Oral SuspensionSCD0ce05282-995c-461e-b807-facb1fcbb4053
239191amoxicillin 50 MG/ML Oral SuspensionSCDbd46de4c-4571-ba9a-e053-2a95a90a792d3
239191amoxicillin 50 MG/ML Oral SuspensionSCD077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY0ce05282-995c-461e-b807-facb1fcbb4053
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYbd46de4c-4571-ba9a-e053-2a95a90a792d3
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY0ce05282-995c-461e-b807-facb1fcbb4053
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYbd46de4c-4571-ba9a-e053-2a95a90a792d3
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin 50 MG/ML Oral SuspensionSCD754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN2177c68d-2884-ce70-e063-6294a90aa2671
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN3e1df272-caf6-4247-8ccf-4e37bfe67e0a1
239191amoxicillin 50 MG/ML Oral SuspensionSCD2177c68d-2884-ce70-e063-6294a90aa2671
239191amoxicillin 50 MG/ML Oral SuspensionSCD3e1df272-caf6-4247-8ccf-4e37bfe67e0a1
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY2177c68d-2884-ce70-e063-6294a90aa2671
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY3e1df272-caf6-4247-8ccf-4e37bfe67e0a1
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY2177c68d-2884-ce70-e063-6294a90aa2671
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY3e1df272-caf6-4247-8ccf-4e37bfe67e0a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9889-0100143988901100 mL in 1 BOTTLE (0143-9889-01) 100 ml2006-06-190000-00-00NoNoCurrent
0143-9889-1500143988915150 mL in 1 BOTTLE (0143-9889-15) 150 ml2006-06-190000-00-00NoNoCurrent
0143-9889-800014398898080 mL in 1 BOTTLE (0143-9889-80) 80 ml2006-06-190000-00-00NoNoCurrent