Home NDC 50383-565-10 Neomycin Sulfate
Product NDC 50383-565
Requested package NDC 50383-565-10
11-digit product format 503830565
Labeler code 50383
Product ID 50383-565_a0fbf585-7be2-41be-95c1-7f0d5d5c1317
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin Sulfate
Dosage form TABLET
Route ORAL
Labeler Hi-Tech Pharmacal Co. Inc.
Application ANDA065220
Marketing category ANDA
Marketing start 2010-03-12
Marketing end 0000-00-00
Substance NEOMYCIN SULFATE
Active strength 500 mg/1
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065220-001 NEOMYCIN SULFATE NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065220-001 AA
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065220-001 NEOMYCIN SULFATE 500MG TABLET / ORAL AA 2006-07-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# 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 · 1 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 50383-565-10 50383056510 100 TABLET in 1 BOTTLE, PLASTIC (50383-565-10) 100 tablet 2010-03-12 0000-00-00 No No Current