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

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42192-374-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42192-374-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42192-374-600efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIACINAMIDE100 ug/1
ZINC2 mg/1
FOLIC ACID850 ug/1
COPPER750 mg/1
SELENIUM50 ug/1
CHROMIUM27 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25X51I8RD4Internal UNII lookup
J41CSQ7QDSInternal UNII lookup
935E97BOY8Internal UNII lookup
789U1901C5Internal UNII lookup
H6241UJ22BInternal UNII lookup
0R0008Q3JBInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
05813526-41d0-4451-8543-f4288ba7eb95Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-374-60EA - Each42192-3743c999ad9-2a33-4444-9baa-1ac1fc7d877012021-06-02

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotinamideNICOTINAMIDEAcella Pharmaceuticals, LLC05813526-41d0-4451-8543-f4288ba7eb952025-02-13WarningsExact identifier
ndc (product): 42192-374

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