Home NDC 50090-1797 Amoxicillin
Product NDC 50090-1797
11-digit product format 500901797
Labeler code 50090
Product ID 50090-1797_4167cee0-6fab-4412-8c16-a1c9feb78e7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA065271
Marketing category ANDA
Marketing start 2005-11-09
Substance AMOXICILLIN
Active strength 500 mg/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 10 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 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-1797-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-1797-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-1797-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-1797-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-1797-0 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A065271-001 AMOXICILLIN AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 A065271-002 AMOXICILLIN AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09
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 · 88 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 2026-10-15 13:18:30 2026-09 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Amoxicillin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 804826J2HU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308191 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-1797-0 Amoxicillin 30 in 1 BOTTLE CAPSULE 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1797 AMOXICILLIN CAPSULE [A-S MEDICATION SOLUTIONS] 6 Current NDC, Legacy NDC, 1 package rows 20241105_05e88717-2ce3-4b1a-88af-c3f61a2d8cd5.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 4 of 4 · 63 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-1797-0 50090179700 30 CAPSULE in 1 BOTTLE (50090-1797-0) 30 capsule 2015-04-29 0000-00-00 No No Current