Amoxicillin

Product NDC
50436-7218
11-digit product format
504367218
Labeler code
50436
Product ID
50436-7218_c0a328ab-4b6e-4a05-8cff-162548ea1696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065291
Marketing category
ANDA
Marketing start
2007-03-01
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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-7218IInactivated by FDA2026-08-17
excluded packagepackage50436-721850436-7218-1IInactivated by FDA2026-08-17
excluded packagepackage50436-721850436-7218-3IInactivated 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 · 57 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 packagepackage50436-7218-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-7218-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-7218-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-7218-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-7218-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-7218-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-7218-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-7218-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-7218-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-7218-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-7218-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-7218-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-7218-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-7218-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-7218-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-7218-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-7218-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-7218-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-7218-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-7218-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-7218-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-7218-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-7218-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-7218-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-7218-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-7218-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-7218-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-7218-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-7218-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-7218-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-7218-3fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-7218-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-7218-386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-7218-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-7218-3bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-7218-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-7218-38dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-7218-18dfbde2a14a4…c9ff85d89658…

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
A065291-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALAB2007-02-05
A065291-002AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALAB2007-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065291-001AB
A065291-002AB

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 06:07:402026-07A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065291-001AMOXICILLIN250MGCAPSULE / ORALAB2007-02-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065291-002AMOXICILLIN500MGCAPSULE / ORALAB2007-02-05bb7c543d1eb4…

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 06:07:402026-07A065291-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065291-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065291-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065291-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065291-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065291-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065291-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065291-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065291-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065291-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065291-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065291-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065291-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065291-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065291-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065291-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065291-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065291-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065291-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065291-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065291-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065291-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065291-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065291-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065291-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065291-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065291-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065291-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065291-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065291-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065291-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065291-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065291-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065291-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065291-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065291-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065291-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065291-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065291-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065291-002AB1bb7c543d1eb4…

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
50436-7218-1Amoxicillin30 in 1 BOTTLECAPSULE305
50436-7218-3Amoxicillin6 in 1 BOTTLECAPSULE65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-7218-3EA - Each50436-72187bb82a24-c0bd-48b2-993a-eb69617a259012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-7218AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]5Legacy NDC, 2 package rows20190129_0dbb3a86-a601-4d40-ab44-01901660181a.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.18a4f555-a537-4c40-9bb2-dc3bd782fa272026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.96057ce7-9516-4239-9974-5e9691b44c9b2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.4fb7837e-964c-4d38-a3a5-b384b1bd6e082026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.039d2677-b04f-436c-e063-6294a90ac5192025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINREMEDYREPACK INC.b6ea2f81-aee6-4c88-b681-50eb28e80a862025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINA-S Medication Solutionsfd071263-b750-4831-9fc5-de112a5f685b2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINA-S Medication Solutionsb988349d-2198-4dbb-a231-9ba37262ce282025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINA-S Medication Solutions364f969d-3037-4dff-b04b-304bca27442e2025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291
AmoxicillinAMOXICILLINA-S Medication Solutions521f7a05-4e6d-447f-b38e-00c4d623703b2025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065291
application number: ANDA065291

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN0dbb3a86-a601-4d40-ab44-01901660181a5
308182amoxicillin 250 MG Oral CapsuleSCD0dbb3a86-a601-4d40-ab44-01901660181a5
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY0dbb3a86-a601-4d40-ab44-01901660181a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-7218-15043672180130 in 1 BOTTLEHistorical
50436-7218-3504367218036 in 1 BOTTLEHistorical