FDA.reportPublic FDA data

Hydroquinone 4%

Product NDC
75834-137
11-digit product format
758340137
Labeler code
75834
Product ID
75834-137_8342b27f-c6a6-44cd-bdbf-54671ef07e0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
CREAM
Route
TOPICAL
Labeler
Nivagen Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-08-17
Substance
HYDROQUINONE
Active strength
40 mg/g
Pharmacologic classes
Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroquinone 4%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROQUINONE40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXV74C1N1AE
Rxcui197795

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-137-012024-02-07C16284748780-11030e365-11bc-111a-e063-dadaa90a10e2HYDROQUINONE 4% CREAM Skin Bleaching Cream Rx Only FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE
75834-137-012024-01-30C16284748780-11030e365-11bc-111a-e063-dadaa90a10e2HYDROQUINONE 4% CREAM Skin Bleaching Cream Rx Only FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-137-01Hydroquinone 4%28.4 g in 1 TUBECREAM28.43
75834-137-01Hydroquinone 4%1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-137-01GM - Gram75834-137479b685d-6e75-401f-bd23-b60b512479a912022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-137HYDROQUINONE 4% (HYDROQUINONE) CREAM [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20240208_7844c308-e0a2-42e7-bd28-f68a59ebca83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197795hydroquinone 4 % Topical CreamPSNba2b7504-17bb-4b9e-8db1-937f83d75a03101
197795hydroquinone 40 MG/ML Topical CreamSCDba2b7504-17bb-4b9e-8db1-937f83d75a03101
197795hydroquinone 4 % Topical CreamSYba2b7504-17bb-4b9e-8db1-937f83d75a03101
197795hydroquinone 4 % Topical CreamPSN7844c308-e0a2-42e7-bd28-f68a59ebca833
197795hydroquinone 40 MG/ML Topical CreamSCD7844c308-e0a2-42e7-bd28-f68a59ebca833
197795hydroquinone 4 % Topical CreamSY7844c308-e0a2-42e7-bd28-f68a59ebca833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-137-01758340137011 TUBE in 1 CARTON (75834-137-01) / 28.4 g in 1 TUBE1 tube2022-08-170000-00-00NoNoCurrent