Amoxicillin

Product NDC
21695-314
11-digit product format
216950314
Labeler code
21695
Product ID
21695-314_0b675f9b-1724-4d56-8e4a-396680de436d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-09-11
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21695-314IInactivated by FDA2026-08-03
excluded packagepackage21695-31421695-314-21IInactivated by FDA2026-08-03
excluded packagepackage21695-31421695-314-30IInactivated 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 2 · 66 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 packagepackage21695-314-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-314-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-314-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-314-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-314-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-314-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-314-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-314-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-314-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-314-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-314-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-314-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-314-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-314-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-314-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-314-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-314-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-314-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-314-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-314-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-314-21367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-314-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-314-21557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-314-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-314-218af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-314-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-314-21834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-314-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-314-211332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-314-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-314-21fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-314-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-314-2186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-314-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-314-21bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-314-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-314-218dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-314-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-314-21e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-314-30e2bbac7714bc…27bdfed8d636…

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
A065271-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALAB2005-11-09
A065271-002AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALAB2005-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065271-001AB
A065271-002AB

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 UTC2026-02A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065271-001AMOXICILLIN250MGCAPSULE / ORALAB2005-11-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A065271-002AMOXICILLIN500MGCAPSULE / ORALAB2005-11-09782e0a99824c…

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 UTC2026-02A065271-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065271-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065271-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065271-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065271-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065271-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065271-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065271-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065271-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065271-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065271-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065271-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065271-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065271-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065271-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065271-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065271-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065271-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065271-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065271-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065271-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065271-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065271-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065271-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065271-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065271-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065271-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065271-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065271-002AB1782e0a99824c…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-314-212019-09-24C16284748780-1934fe258-4d25-48b1-e053-8cdaa90a720aAmoxicillin Capsules, USP
21695-314-302019-09-24C16284748780-1934fe258-4d25-48b1-e053-8cdaa90a720aAmoxicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-314-21Amoxicillin21 in 1 BOTTLECAPSULE211
21695-314-30Amoxicillin500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-314-21EA - Each21695-314d17fa94f-c10a-46a0-8b70-b514c4035de012012-07-24
21695-314-30EA - Each21695-3141b16039e-b0a4-4f4b-a66a-2ae3c6aae45812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-314AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20100202_b41ecd6b-4c54-44c8-aa3f-1868faad07c6.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 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4a402dba-c255-5db8-e054-00144ff8d46c2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8cb987bf-d45a-c15a-e053-2995a90aad462026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINHAWAII REPACK, INC.bf130964-8386-4ab7-8d3b-fb0174670afc2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNorthwind Health Company, LLC1d0d8bc4-137e-ef10-e063-6294a90acf622026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINREMEDYREPACK INC.53548597-347b-42a9-916c-e88cd27b8dcd2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINREMEDYREPACK INC.3a4afd36-dffa-44a1-9d09-e93cf66053bf2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINProficient Rx LPef03286b-4ba7-4952-9ab1-90cacf3005042026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5155ca5d-fe58-42b4-e063-6394a90ab1352026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINCoupler LLC5020950a-b248-a463-e063-6294a90ae57f2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINREMEDYREPACK INC.afb4149a-0714-4a85-b9e8-2379a8e6a3022026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINSportpharm LLC9bb2856b-feef-4063-befc-2dd9175028982026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINPreferred Phamraceuticals Inc.47424822-14a1-48e0-a62d-df34fe6857262026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.d6a33b28-f520-4a4c-b553-0ebd005583452026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.800f5fac-f2af-358f-e053-2a91aa0ad6a62026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINSportpharm LLCd55dd9d9-e901-47b6-b496-5f2749726a2e2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
Amoxicillin 500 mgAMOXICILLINHealth Department, Oklahoma Statef049551b-4708-eb13-e053-2a95a90afd1f2025-12-13Exact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINAsclemed USA, Inc.32b224c2-1354-4b58-b082-b93330e6962b2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINQPharma Inc2772a745-1276-405b-b229-95edf5534b2a2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.071086f5-e4ed-b1d9-e063-6294a90ad3042025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271
AmoxicillinAMOXICILLINBryant Ranch Prepackbbaeb509-ad04-4668-a1db-4358038893f22025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065271
application number: ANDA065271

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSNb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin 500 MG Oral CapsulePSNb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin 250 MG Oral CapsuleSCDb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin 500 MG Oral CapsuleSCDb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb41ecd6b-4c54-44c8-aa3f-1868faad07c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-314-212169503142121 in 1 BOTTLEHistorical
21695-314-3021695031430500 in 1 BOTTLEHistorical