Home NDC 42192-374 Nicotinamide
Product NDC 42192-374
11-digit product format 421920374
Labeler code 42192
Product ID 42192-374_55f85d14-1d83-20e5-e063-6294a90aa945
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicotinamide
Dosage form TABLET
Route ORAL
Labeler Acella Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2021-05-25
Substance NIACINAMIDE; ZINC GLYCINATE; LEVOMEFOLATE CALCIUM; CUPRIC OXIDE; SELENIUM; CHROMIUM
Active strength 750; 27; 500; 2; 50; 100 mg/1; mg/1; ug/1; mg/1; ug/1; ug/1
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 6 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 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42192-374-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42192-374-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42192-374-60 0efc9e666f02…f202fb6c5f17…
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 Nicotinamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIACINAMIDE 750 mg/1 ZINC GLYCINATE 27 mg/1 LEVOMEFOLATE CALCIUM 500 ug/1 CUPRIC OXIDE 2 mg/1 SELENIUM 50 ug/1 CHROMIUM 100 ug/1
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 42192-374-60 Nicotinamide 60 in 1 BOTTLE TABLET 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42192-374 NICOTINAMIDE TABLET [ACELLA PHARMACEUTICALS, LLC ] 5 Current NDC, 1 package rows 20250215_05813526-41d0-4451-8543-f4288ba7eb95.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42192-374-60 42192037460 60 TABLET in 1 BOTTLE (42192-374-60) 60 tablet 2021-05-25 No No Current