Amoxicillin

Product NDC
70934-054
11-digit product format
709340054
Labeler code
70934
Product ID
70934-054_d202d019-b21d-6d86-e053-2a95a90a0dc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA064076
Marketing category
ANDA
Marketing start
2017-12-20
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-054IInactivated by FDA2026-08-03
excluded packagepackage70934-05470934-054-14IInactivated by FDA2026-08-03
excluded packagepackage70934-05470934-054-20IInactivated by FDA2026-08-03
excluded packagepackage70934-05470934-054-21IInactivated by FDA2026-08-03
excluded packagepackage70934-05470934-054-30IInactivated by FDA2026-08-03
excluded packagepackage70934-05470934-054-40IInactivated by FDA2026-08-03
excluded packagepackage70934-05470934-054-92IInactivated by FDA2026-08-03
excluded packagepackage70934-05470934-054-93IInactivated by FDA2026-08-03
excluded packagepackage70934-05470934-054-94IInactivated 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 3 · 135 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 packagepackage70934-054-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-054-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-054-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-054-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-054-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-054-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-054-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-054-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-054-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-054-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-054-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-054-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-054-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-054-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-054-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-054-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-054-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-054-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-054-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-054-932ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-054-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-054-942ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-054-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-054-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-054-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-054-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-054-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-054-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-054-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-054-94a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-054-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-054-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-054-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-054-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-054-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-054-93cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-054-92cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-054-94cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-054-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-054-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-054-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-054-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-054-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-054-93cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-054-92cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-054-94cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-054-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-054-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-054-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-054-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-054-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-054-93302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-054-92302b2466d912…e7b80fea0513…

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
A064076-001AMOXICILLINAMOXICILLIN250MGCAPSULE / ORALAB1994-09-30
A064076-002AMOXICILLINAMOXICILLIN500MGCAPSULE / ORALAB1994-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064076-001AB
A064076-002AB

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 UTC2026-02A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064076-001AMOXICILLIN250MGCAPSULE / ORALAB1994-09-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A064076-002AMOXICILLIN500MGCAPSULE / ORALAB1994-09-30782e0a99824c…

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 UTC2026-02A064076-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064076-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064076-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064076-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064076-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064076-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064076-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064076-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064076-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064076-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064076-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064076-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064076-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064076-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064076-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064076-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064076-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064076-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064076-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A064076-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064076-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064076-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064076-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064076-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064076-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064076-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064076-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064076-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064076-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064076-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064076-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064076-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064076-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064076-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064076-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064076-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064076-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064076-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064076-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A064076-002AB1782e0a99824c…

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, Related label table
NDCRelated label
70934-054-14These highlights do not include all the information needed to use AMOXICILLIN Capsules safely and effectively. See full prescribing information for AMOXICILLIN Capsules AMOXICILLIN Capsules Initial U.S. Approval: 1974
70934-054-20These highlights do not include all the information needed to use AMOXICILLIN Capsules safely and effectively. See full prescribing information for AMOXICILLIN Capsules AMOXICILLIN Capsules Initial U.S. Approval: 1974
70934-054-21These highlights do not include all the information needed to use AMOXICILLIN Capsules safely and effectively. See full prescribing information for AMOXICILLIN Capsules AMOXICILLIN Capsules Initial U.S. Approval: 1974
70934-054-30These highlights do not include all the information needed to use AMOXICILLIN Capsules safely and effectively. See full prescribing information for AMOXICILLIN Capsules AMOXICILLIN Capsules Initial U.S. Approval: 1974
70934-054-40These highlights do not include all the information needed to use AMOXICILLIN Capsules safely and effectively. See full prescribing information for AMOXICILLIN Capsules AMOXICILLIN Capsules Initial U.S. Approval: 1974
70934-054-92These highlights do not include all the information needed to use AMOXICILLIN Capsules safely and effectively. See full prescribing information for AMOXICILLIN Capsules AMOXICILLIN Capsules Initial U.S. Approval: 1974
70934-054-93These highlights do not include all the information needed to use AMOXICILLIN Capsules safely and effectively. See full prescribing information for AMOXICILLIN Capsules AMOXICILLIN Capsules Initial U.S. Approval: 1974
70934-054-94These highlights do not include all the information needed to use AMOXICILLIN Capsules safely and effectively. See full prescribing information for AMOXICILLIN Capsules AMOXICILLIN Capsules Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-054-14Amoxicillin14 in 1 BOTTLE, PLASTICCAPSULE149
70934-054-20Amoxicillin20 in 1 BOTTLE, PLASTICCAPSULE209
70934-054-21Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE219
70934-054-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE309
70934-054-40Amoxicillin40 in 1 BOTTLE, PLASTICCAPSULE409
70934-054-92Amoxicillin21 in 1 DOSE PACKCAPSULE219
70934-054-93Amoxicillin28 in 1 DOSE PACKCAPSULE289
70934-054-94Amoxicillin30 in 1 DOSE PACKCAPSULE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-054-20EA - Each70934-054d8d5e806-dcdd-4dc6-ba72-7ad5c58e257712018-02-20
70934-054-21EA - Each70934-05414960dbe-dc02-48d2-876f-de3e3de21ce912018-02-20
70934-054-30EA - Each70934-05442a93233-51cb-4221-9399-abf042eb2fca12018-02-20
70934-054-40EA - Each70934-054bf7da7f8-ea16-4ff9-b667-8e646211ab4012018-02-20
70934-054-93EA - Each70934-0549fb0f6b7-353d-4216-8f93-7732a12b0ccf12018-11-06
70934-054-94EA - Each70934-0546b3cc665-84a5-4bb3-b7d1-14c660d8577312018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-054AMOXICILLIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]9Legacy NDC, 8 package rows20211230_61ceb6f4-3edf-4675-e053-2991aa0a086e.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINREMEDYREPACK INC.102c62ca-da20-4866-84a8-e3513824af4a2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINNorthwind Health Company, LLC4ecefd37-9847-1d93-e063-6394a90a19f02026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINCoupler LLC52bd03c6-528a-c443-e063-6394a90aad392026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepackbe7d8459-b8e6-499a-ab87-99bd174925252026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINQPharma Incddd1307d-3216-0e59-e053-2995a90ad19d2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINCoupler LLC50fff2b8-8bf1-ff46-e063-6394a90a92132026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINREMEDYREPACK INC.82c0c5d1-df2d-4352-bd12-99f955af569e2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINREMEDYREPACK INC.bb95fd06-f200-4de3-bfae-84d642d8e0f32026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.76ba0f8d-4d1c-a5ff-e053-2a91aa0a75552024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.6e9bf369-2f96-c7ae-e053-2a91aa0a715f2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepack7b182161-128e-430c-98b2-592c242ba7112024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepack260a3a79-9dd6-4c4b-82ec-f8050346e8862024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepackaee851cf-428e-4d29-a281-078fe00c56b02024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepack9925773d-8ea1-4193-91e3-52cc1ce5ca672024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINSandoz Inc13bd4214-9b7f-425b-af5f-fc1ddc6782302024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINBryant Ranch Prepackc5d39ce2-8ae4-4bba-893f-a713afba18932023-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINAsclemed USA, Inc.f27237d7-123a-44ba-97df-b2446a94e3e52021-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076
AmoxicillinAMOXICILLINProficient Rx LP9528a356-4101-4be2-a7e2-b0659e169e1a2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064076
application number: ANDA064076

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN61ceb6f4-3edf-4675-e053-2991aa0a086e9
308191amoxicillin 500 MG Oral CapsuleSCD61ceb6f4-3edf-4675-e053-2991aa0a086e9
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY61ceb6f4-3edf-4675-e053-2991aa0a086e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-054-147093400541414 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-14) 14 capsule2020-06-160000-00-00NoNoCurrent
70934-054-207093400542020 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-20) 20 capsule2018-01-030000-00-00NoNoCurrent
70934-054-217093400542121 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-21) 21 capsule2017-12-200000-00-00NoNoCurrent
70934-054-307093400543030 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-30) 30 capsule2017-12-200000-00-00NoNoCurrent
70934-054-407093400544040 CAPSULE in 1 BOTTLE, PLASTIC (70934-054-40) 40 capsule2017-12-200000-00-00NoNoCurrent
70934-054-927093400549221 CAPSULE in 1 DOSE PACK (70934-054-92) 21 capsule2018-01-180000-00-00NoNoCurrent
70934-054-937093400549328 CAPSULE in 1 DOSE PACK (70934-054-93) 28 capsule2018-07-100000-00-00NoNoCurrent
70934-054-947093400549430 CAPSULE in 1 DOSE PACK (70934-054-94) 30 capsule2018-01-180000-00-00NoNoCurrent