Home NDC 63187-044 Amoxicillin
Product NDC 63187-044
11-digit product format 631870044
Labeler code 63187
Product ID 63187-044_46acdbce-70d1-462a-b60c-cd242b654e3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA062058
Marketing category ANDA
Marketing start 2012-01-12
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-044-30 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-044-21 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-044-40 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-044-30 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-044-21 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-044-40 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062058-001 AMOXICILLIN AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 A062058-002 AMOXICILLIN AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062058-001 AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062058-002 AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-044 AMOXICILLIN CAPSULE [PROFICIENT RX LP] 4 Legacy NDC 20191121_70231a3f-e266-488f-bdfa-d88e3da3464f.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63187-044-21 63187004421 21 CAPSULE in 1 BOTTLE (63187-044-21) 21 capsule 2018-11-01 0000-00-00 No No Current 63187-044-30 63187004430 30 CAPSULE in 1 BOTTLE (63187-044-30) 30 capsule 2018-11-01 0000-00-00 No No Current 63187-044-40 63187004440 40 CAPSULE in 1 BOTTLE (63187-044-40) 40 capsule 2018-11-01 0000-00-00 No No Current