Home NDC 75834-137 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 Ingredient Strength HYDROQUINONE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XV74C1N1AE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197795 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 75834-137-01 Hydroquinone 4% 28.4 g in 1 TUBE CREAM 28.4 3 75834-137-01 Hydroquinone 4% 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-137 HYDROQUINONE 4% (HYDROQUINONE) CREAM [NIVAGEN PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240208_7844c308-e0a2-42e7-bd28-f68a59ebca83.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75834-137-01 75834013701 1 TUBE in 1 CARTON (75834-137-01) / 28.4 g in 1 TUBE 1 tube 2022-08-17 0000-00-00 No No Current