AZELAIC ACID 15% / NIACINAMIDE 4%

Product NDC: 72934-2008
11-digit product format: 729342008
Labeler code: 72934
Product ID: 72934-2008_87391cb8-def8-a107-e053-2991aa0a561b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AZELAIC ACID 15% / NIACINAMIDE 4%
Dosage form: CREAM
Route: TOPICAL
Labeler: Sincerus Florida, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2019-05-01
Marketing end: 0000-00-00
Substance: AZELAIC ACID; NIACINAMIDE
Active strength: 15 g/100g; g/100g
Pharmacologic classes: Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72934-2008		I	Inactivated by FDA		2026-07-31
excluded package	package	72934-2008	72934-2008-2	I	Inactivated by FDA		2026-07-31

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c6fc281-9445-2e9e-1c29-a09ddbc4299c	Product name	2	20200213
2a856070-cbe7-4f85-be0f-09885ff91196	Product name	1	20150806

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72934-2008-2	2021-01-29	C162847	48780-1	ba0f9c33-44a3-a910-e053-dadaa90a0b85	AZELAIC ACID 15% / NIACINAMIDE 4%

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72934-2008-2	AZELAIC ACID 15% / NIACINAMIDE 4%	30 g in 1 BOTTLE, PUMP	CREAM	30		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72934-2008-2	GM - Gram	72934-2008	62216be2-50a8-409c-85fa-619cf2d54548	1	2020-03-10

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72934-2008	AZELAIC ACID 15% / NIACINAMIDE 4% CREAM [SINCERUS FLORIDA, LLC]	1	Legacy NDC, 1 package rows	20190501_87391cb8-def7-a107-e053-2991aa0a561b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F2VW3D43YT	AZELAIC ACID	123-99-9	AZELAIC ACID
25X51I8RD4	NIACINAMIDE	98-92-0	NIACINAMIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
72934-2008-2	72934200802	30 g in 1 BOTTLE, PUMP	30 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AZELAIC ACID 15% / NIACINAMIDE 4%	Sincerus Florida, LLC	2019-04-23	HUMAN PRESCRIPTION DRUG LABEL	1