Home NDC 65162-512-50 Salsalate
Product NDC 65162-512
Requested package NDC 65162-512-50
11-digit product format 651620512
Labeler code 65162
Product ID 65162-512_6b990a95-3932-4771-adb1-84bfe4c456de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Salsalate
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2010-09-24
Substance SALSALATE
Active strength 500 mg/1
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65162-512 65162-512-50 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65162-512 65162-512-50 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base Salsalate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALSALATE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9MO595C9I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312899 Internal RxNorm lookup 583170 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65162-512-10 Salsalate 100 in 1 BOTTLE TABLET 100 14 65162-512-11 Salsalate 1000 in 1 BOTTLE TABLET 1000 14 65162-512-50 Salsalate 500 in 1 BOTTLE TABLET 500 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-512 SALSALATE TABLET [AMNEAL PHARMACEUTICALS LLC] 14 Current NDC, Legacy NDC, 3 package rows 20241031_213f0930-4a4a-4894-90b9-70c12daaa093.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 · 1 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 65162-512-50 65162051250 500 TABLET in 1 BOTTLE (65162-512-50) 500 tablet 2010-09-24 0000-00-00 No No Current