FDA.reportPublic FDA data

Nicotinamide

Product NDC
42192-374
11-digit product format
421920374
Labeler code
42192
Product ID
42192-374_e03ca6f2-c438-4b0a-9c19-db16e88697ac
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
CHROMIUM; COPPER; FOLIC ACID; NIACINAMIDE; SELENIUM; ZINC
Active strength
100; 2; 850; 750; 50; 27 ug/1; mg/1; ug/1; mg/1; ug/1; mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotinamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHROMIUM100 ug/1
COPPER2 mg/1
FOLIC ACID850 ug/1
NIACINAMIDE750 mg/1
SELENIUM50 ug/1
ZINC27 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0R0008Q3JB, 789U1901C5, 935E97BOY8, 25X51I8RD4, H6241UJ22B, J41CSQ7QDS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42192-374-602025-02-13C16284748780-12cef2736-600c-d83d-e063-dadaa90ab31fNICOTINAMIDE
42192-374-602025-01-30C16284748780-12cef2736-600c-d83d-e063-dadaa90ab31fNICOTINAMIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-374-60Nicotinamide60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-374NICOTINAMIDE TABLET [ACELLA PHARMACEUTICALS, LLC ]5Current NDC, 1 package rows20250215_05813526-41d0-4451-8543-f4288ba7eb95.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42192-374-604219203746060 TABLET in 1 BOTTLE (42192-374-60) 60 tablet2021-05-25NoNoCurrent