Amoxicillin

Product NDC
65862-015
11-digit product format
658620015
Labeler code
65862
Product ID
65862-015_ee0e12cd-e881-4048-a0fb-74bd771cb9aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
875 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 productproduct65862-015UNFINISHEDActive or certified unfinished drug listing2026-08-12
unfinished packagepackage65862-01565862-015-89UNFINISHEDActive or certified unfinished drug listing2026-08-12
unfinished packagepackage65862-01565862-015-99UNFINISHEDActive or certified unfinished drug listing2026-08-12

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 packagepackage65862-015-99a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-015-89a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-015-991d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-015-891d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-015-99390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-015-89390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-015-99e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-015-89e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-015-99bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-015-89bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-015-99f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-015-89f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-015-99f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-015-89f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-015-9968b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-015-8968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-015-9905c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-015-8905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-015-9948b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-015-8948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-015-9927f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-015-8927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-015-998d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-015-898d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-015-99d1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-015-89d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-015-9950b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-015-8950b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-015-89906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-015-99906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-015-896db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-015-996db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-015-898fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-015-998fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-015-994184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-015-894184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-015-994bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-015-894bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-015-99263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-015-89263afe128892…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
A065256-001AMOXICILLINAMOXICILLIN500MGTABLET / ORALAB2005-11-09
A065256-002AMOXICILLINAMOXICILLIN875MGTABLET / 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
A065256-001AB
A065256-002AB

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 UTC2026-02A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065256-002AMOXICILLIN875MGTABLET / ORALAB2005-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065256-001AMOXICILLIN500MGTABLET / ORALAB2005-11-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A065256-002AMOXICILLIN875MGTABLET / 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 UTC2026-02A065256-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065256-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065256-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065256-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065256-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065256-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065256-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065256-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065256-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065256-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065256-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065256-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065256-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065256-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065256-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065256-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065256-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065256-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065256-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065256-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065256-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065256-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065256-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065256-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065256-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065256-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065256-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065256-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065256-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 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
308192Internal RxNorm lookup
308194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99103779-6d2f-4e4b-9b7f-0b24d7c6bf4eAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-015-01Amoxicillin100 in 1 BOTTLETABLET, FILM COATED10017
65862-015-05Amoxicillin500 in 1 BOTTLETABLET, FILM COATED50017
65862-015-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-015-01EA - Each65862-015db23ecaa-6809-4e97-bcfb-9dc3c742b76c12012-07-24
65862-015-05EA - Each65862-0159b386731-410c-4274-8a2a-66c42428d18712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [REDPHARM DRUG INC.]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN (AMOXICILLIN TABLET, FILM COATED) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-015AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 3 package rows20240613_99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINCoupler LLC5827b6de-6b48-d73a-e063-6394a90a4a722026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINREMEDYREPACK INC.a2c91cf0-a4e4-44c0-b712-bee63dd6c22b2026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINREMEDYREPACK INC.9618d038-e880-47f6-b8d7-bbf8ab35364d2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINREMEDYREPACK INC.f37eb415-77b2-41b0-8d20-64e821e4b05d2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINProficient Rx LP313ea909-5b1b-41ff-a0db-5aadc12e2e4f2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINCoupler LLC5037e2a5-52e9-caec-e063-6294a90ad8372026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINAmerican Health Packagingd339ea0f-8797-460f-a3b7-b8455c2503662026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.4b23e6f5-9287-4c01-b795-b8c5388330392026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.f1eee459-9021-b26e-e053-2995a90a72912026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINQPharma, Inc.2700df91-c5ef-4931-9ad7-a3c1c146ccac2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8e6f9df1-0754-69e4-e053-2a95a90acc492025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.3e4f0f03-438b-ddfb-e063-6294a90adb382025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.3880b9c2-62a5-0d23-e063-6394a90a12522025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINA-S Medication Solutionsb91f40dd-40db-473d-a399-166aeb1ce7e22025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINA-S Medication Solutionsaaf42367-153e-4525-af5f-f5f1c7d6c5592024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINBryant Ranch Prepackbef50f2a-78c6-4d0c-8ad9-cfa3c801629d2024-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.963986fc-0e59-21b0-e053-2a95a90a95312024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINA-S Medication Solutionsc3d3f94f-e976-4625-9667-3d716932f2fa2024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.20eb4ade-f3b8-db66-e063-6294a90ae8462024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256
AmoxicillinAMOXICILLINAsclemed USA, Inc.a18751fa-6202-4ae2-950a-a3f1dc9a8afd2024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065256
application number: ANDA065256

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSNc3d3f94f-e976-4625-9667-3d716932f2fa29
308194amoxicillin 875 MG Oral TabletPSNc3d3f94f-e976-4625-9667-3d716932f2fa29
308192amoxicillin 500 MG Oral TabletSCDc3d3f94f-e976-4625-9667-3d716932f2fa29
308194amoxicillin 875 MG Oral TabletSCDc3d3f94f-e976-4625-9667-3d716932f2fa29
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYc3d3f94f-e976-4625-9667-3d716932f2fa29
308192amoxicillin 500 MG Oral TabletPSN99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308194amoxicillin 875 MG Oral TabletPSN99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308192amoxicillin 500 MG Oral TabletSCD99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308194amoxicillin 875 MG Oral TabletSCD99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e17
308194amoxicillin 875 MG Oral TabletPSN9618d038-e880-47f6-b8d7-bbf8ab35364d16
308194amoxicillin 875 MG Oral TabletSCD9618d038-e880-47f6-b8d7-bbf8ab35364d16
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY9618d038-e880-47f6-b8d7-bbf8ab35364d16
308194amoxicillin 875 MG Oral TabletPSN00fbd46e-05fd-4f8a-9f59-a7a4d01c8e5414
308194amoxicillin 875 MG Oral TabletSCD00fbd46e-05fd-4f8a-9f59-a7a4d01c8e5414
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY00fbd46e-05fd-4f8a-9f59-a7a4d01c8e5414
308194amoxicillin 875 MG Oral TabletPSN2700df91-c5ef-4931-9ad7-a3c1c146ccac7
308194amoxicillin 875 MG Oral TabletSCD2700df91-c5ef-4931-9ad7-a3c1c146ccac7
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY2700df91-c5ef-4931-9ad7-a3c1c146ccac7
308194amoxicillin 875 MG Oral TabletPSN586a5911-e30b-40ed-a056-9e67920ca9513
308194amoxicillin 875 MG Oral TabletSCD586a5911-e30b-40ed-a056-9e67920ca9513
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY586a5911-e30b-40ed-a056-9e67920ca9513
308194amoxicillin 875 MG Oral TabletPSN31c12a11-7bce-4457-b413-feaad0da9c492
308194amoxicillin 875 MG Oral TabletPSN271ddc63-b31b-2f46-e054-00144ff8d46c2
308194amoxicillin 875 MG Oral TabletPSN7a15d4c8-d214-446a-8d24-8b2defdf8e022
308194amoxicillin 875 MG Oral TabletPSN5037e2a5-52e9-caec-e063-6294a90ad8372
308194amoxicillin 875 MG Oral TabletSCD5037e2a5-52e9-caec-e063-6294a90ad8372
308194amoxicillin 875 MG Oral TabletSCD7a15d4c8-d214-446a-8d24-8b2defdf8e022
308194amoxicillin 875 MG Oral TabletSCD271ddc63-b31b-2f46-e054-00144ff8d46c2
308194amoxicillin 875 MG Oral TabletSCD31c12a11-7bce-4457-b413-feaad0da9c492
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY31c12a11-7bce-4457-b413-feaad0da9c492
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY5037e2a5-52e9-caec-e063-6294a90ad8372
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY271ddc63-b31b-2f46-e054-00144ff8d46c2
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY7a15d4c8-d214-446a-8d24-8b2defdf8e022
308194amoxicillin 875 MG Oral TabletPSNbc4ce768-a615-4458-9d60-baeada6886cd1
308194amoxicillin 875 MG Oral TabletPSN6b577898-b36a-425c-8cf3-36230347b2d21
308194amoxicillin 875 MG Oral TabletPSN9179bb1b-8554-4c00-a323-aac951ae2f551
308194amoxicillin 875 MG Oral TabletSCD9179bb1b-8554-4c00-a323-aac951ae2f551
308194amoxicillin 875 MG Oral TabletSCDbc4ce768-a615-4458-9d60-baeada6886cd1
308194amoxicillin 875 MG Oral TabletSCD6b577898-b36a-425c-8cf3-36230347b2d21
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYbc4ce768-a615-4458-9d60-baeada6886cd1
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY9179bb1b-8554-4c00-a323-aac951ae2f551
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY6b577898-b36a-425c-8cf3-36230347b2d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-015-0165862001501100 TABLET, FILM COATED in 1 BOTTLE (65862-015-01) 2005-11-090000-00-00NoNoCurrent
65862-015-0565862001505500 TABLET, FILM COATED in 1 BOTTLE (65862-015-05) 2005-11-090000-00-00NoNoCurrent
65862-015-206586200152020 TABLET, FILM COATED in 1 BOTTLE (65862-015-20) 2005-11-090000-00-00NoNoCurrent
65862-015-8965862001589900 TABLET, FILM COATED in 1 BAG (65862-015-89)09-NOV-05Current
65862-015-99658620015991000 TABLET, FILM COATED in 1 BAG (65862-015-99)09-NOV-05Current