HALCINONIDE

Product NDC
57664-698
11-digit product format
576640698
Labeler code
57664
Product ID
57664-698_4139dd4b-7346-876e-e063-6394a90a5c1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALCINONIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA017556
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-05-22
Substance
HALCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALCINONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSI86V6QNEG
Rxcui103467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
37520c8a-9139-9e9d-9bd5-8abdb9be6b07Product name320220311
8582553f-f57a-db33-d781-0d1306d11142Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-698-36HALCINONIDE1 in 1 CARTONCREAM14
57664-698-36HALCINONIDE60 g in 1 TUBECREAM604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-698-36GM - Gram57664-698d1d360f4-a4ce-4a3e-8d26-9f0db6791a7912021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-698HALCINONIDE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]2Current NDC, Legacy NDC, 2 package rows20210529_aed461bb-e49e-44c4-b42f-b5b261c072a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103467halcinonide 0.1 % Topical CreamPSNaed461bb-e49e-44c4-b42f-b5b261c072a04
103467halcinonide 1 MG/ML Topical CreamSCDaed461bb-e49e-44c4-b42f-b5b261c072a04
103467halcinonide 0.1 % Topical CreamSYaed461bb-e49e-44c4-b42f-b5b261c072a04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-698-36576640698361 TUBE in 1 CARTON (57664-698-36) / 60 g in 1 TUBE1 tube2021-05-220000-00-00NoNoCurrent