Amoxicillin

Product NDC
65862-016
11-digit product format
658620016
Labeler code
65862
Product ID
65862-016_4dc94f3c-990d-476f-a88e-df9967570eec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
250 mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-016UNFINISHEDActive or certified unfinished drug listing2026-08-03
unfinished packagepackage65862-01665862-016-18UNFINISHEDActive or certified unfinished drug listing2026-08-03
unfinished packagepackage65862-01665862-016-22UNFINISHEDActive or certified unfinished drug listing2026-08-03

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 · 63 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 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-016-18a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-016-22a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-016-181d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-016-221d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-016-18390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-016-22390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-016-18e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-016-22e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-016-18bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-016-22bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-016-18f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-016-22f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-016-18f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-016-22f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-016-1868b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-016-2268b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-016-1805c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-016-2205c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-016-1848b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-016-2248b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-016-1827f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-016-2227f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-016-188d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-016-228d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-016-18d1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-016-22d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-016-1850b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-016-2250b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-016-22906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-016-18906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-016-226db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-016-186db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-016-228fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-016-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-016-184184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-016-224184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-016-184bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-016-224bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-016-18263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-016-22263afe128892…91768de4ddbe…

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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 mg/1

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
308182Internal RxNorm lookup
308191Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7e3a4517-1934-4e03-b96b-4ad65ab076c5Available 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
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-016-01Amoxicillin100 in 1 BOTTLECAPSULE10020
65862-016-05Amoxicillin500 in 1 BOTTLECAPSULE50020
65862-016-20Amoxicillin20 in 1 BOTTLECAPSULE2020
65862-016-30Amoxicillin30 in 1 BOTTLECAPSULE3020
65862-016-50Amoxicillin50 in 1 BOTTLECAPSULE5020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-016-01EA - Each65862-016a3852356-d164-4277-96b2-73a7e54c718612012-07-24
65862-016-05EA - Each65862-0160f36be81-af4b-4f37-915a-941fdbe359f012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]12
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [STAT RX USA LLC]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [STAT RX USA LLC]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [STAT RX USA LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [STAT RX USA LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [STAT RX USA LLC]2
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [STAT RX USA LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [STAT RX USA LLC]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [APOTHECA INC.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN CAPSULE [APOTHECA INC.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [APOTHECA INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [APOTHECA INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [APOTHECA INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [APOTHECA INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [APOTHECA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [APOTHECA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [APOTHECA INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [APOTHECA INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN (AMOXICILLIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-016AMOXICILLIN CAPSULE [AUROBINDO PHARMA LIMITED]20Current NDC, Legacy NDC, 5 package rows20240203_7e3a4517-1934-4e03-b96b-4ad65ab076c5.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 CapsulePSN7e3a4517-1934-4e03-b96b-4ad65ab076c520
308191amoxicillin 500 MG Oral CapsulePSN7e3a4517-1934-4e03-b96b-4ad65ab076c520
308182amoxicillin 250 MG Oral CapsuleSCD7e3a4517-1934-4e03-b96b-4ad65ab076c520
308191amoxicillin 500 MG Oral CapsuleSCD7e3a4517-1934-4e03-b96b-4ad65ab076c520
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY7e3a4517-1934-4e03-b96b-4ad65ab076c520
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY7e3a4517-1934-4e03-b96b-4ad65ab076c520
308182amoxicillin 250 MG Oral CapsulePSN8f8b1fe6-23cb-2105-e053-2a95a90aeede5
308182amoxicillin 250 MG Oral CapsuleSCD8f8b1fe6-23cb-2105-e053-2a95a90aeede5
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY8f8b1fe6-23cb-2105-e053-2a95a90aeede5
308182amoxicillin 250 MG Oral CapsulePSNf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin 500 MG Oral CapsulePSNf884225c-7845-4df1-ba35-dc53010ed0b04
308182amoxicillin 250 MG Oral CapsuleSCDf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin 500 MG Oral CapsuleSCDf884225c-7845-4df1-ba35-dc53010ed0b04
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYf884225c-7845-4df1-ba35-dc53010ed0b04
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYf884225c-7845-4df1-ba35-dc53010ed0b04
308182amoxicillin 250 MG Oral CapsulePSN78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin 250 MG Oral CapsulePSNfc61c9f5-b0f8-3ff8-e053-6394a90adeb72
308191amoxicillin 500 MG Oral CapsulePSN78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin 250 MG Oral CapsuleSCD78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin 250 MG Oral CapsuleSCDfc61c9f5-b0f8-3ff8-e053-6394a90adeb72
308191amoxicillin 500 MG Oral CapsuleSCD78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYfc61c9f5-b0f8-3ff8-e053-6394a90adeb72
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY78cabf7c-f342-4285-bc5a-9f24789d44ed2
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY78cabf7c-f342-4285-bc5a-9f24789d44ed2
308182amoxicillin 250 MG Oral CapsulePSN1c755ad7-f0a8-4a63-a686-413bae57f8d01
308182amoxicillin 250 MG Oral CapsulePSN9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308182amoxicillin 250 MG Oral CapsulePSNa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308182amoxicillin 250 MG Oral CapsulePSNb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin 500 MG Oral CapsulePSN9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308191amoxicillin 500 MG Oral CapsulePSNa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin 500 MG Oral CapsulePSNb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin 250 MG Oral CapsuleSCD9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308182amoxicillin 250 MG Oral CapsuleSCDb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin 250 MG Oral CapsuleSCDa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308182amoxicillin 250 MG Oral CapsuleSCD1c755ad7-f0a8-4a63-a686-413bae57f8d01
308191amoxicillin 500 MG Oral CapsuleSCDb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin 500 MG Oral CapsuleSCDa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin 500 MG Oral CapsuleSCD9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY1c755ad7-f0a8-4a63-a686-413bae57f8d01
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb41ecd6b-4c54-44c8-aa3f-1868faad07c61
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYa8b3caf1-31c3-4a78-9e74-7a1e3968a0ec1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY9cd42f6f-cc7a-43f5-98dd-a5d6210933ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-016-0165862001601100 CAPSULE in 1 BOTTLE (65862-016-01) 100 capsule2005-11-090000-00-00NoNoCurrent
65862-016-0565862001605500 CAPSULE in 1 BOTTLE (65862-016-05) 500 capsule2005-11-090000-00-00NoNoCurrent
65862-016-18658620016181800 CAPSULE in 1 BAG (65862-016-18)1800 capsule11-SEP-05Current
65862-016-206586200162020 CAPSULE in 1 BOTTLE (65862-016-20) 20 capsule2005-11-090000-00-00NoNoCurrent
65862-016-22658620016222000 CAPSULE in 1 BAG (65862-016-22)2000 capsule11-SEP-05Current
65862-016-306586200163030 CAPSULE in 1 BOTTLE (65862-016-30) 30 capsule2005-11-090000-00-00NoNoCurrent
65862-016-506586200165050 CAPSULE in 1 BOTTLE (65862-016-50) 50 capsule2005-11-090000-00-00NoNoCurrent