FDA.reportPublic FDA data

RYCLORA

Product NDC
15370-150
11-digit product format
153700150
Labeler code
15370
Product ID
15370-150_3affdd03-252d-443c-9966-e3aec314fb98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexchlorpheniramine Maleate
Dosage form
LIQUID
Route
ORAL
Labeler
CARWIN PHARMACEUTICAL ASSOCIATES, LLC
Application
ANDA202520
Marketing category
ANDA
Marketing start
2018-10-07
Substance
DEXCHLORPHENIRAMINE MALEATE
Active strength
2 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXCHLORPHENIRAMINE MALEATE2 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB10YD955QW
Rxcui2183907, 2183912

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44893bf2-1be4-4e68-8bc4-bbb0f543085eProduct name120180830

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15370-150-04RYCLORA118 mL in 1 BOTTLE, PLASTICLIQUID1182
15370-150-16RYCLORA473 mL in 1 BOTTLE, PLASTICLIQUID4732
15370-150-99RYCLORA20 mL in 1 BOTTLE, PLASTICLIQUID202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15370-150-04ML - Milliliter15370-150a77c55bc-c83a-4f41-8b4c-fd2d4df7449b12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15370-150RYCLORA (DEXCHLORPHENIRAMINE MALEATE) LIQUID [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]2Current NDC, Legacy NDC, 3 package rows20240109_aa4f80c9-e600-4bc0-8528-02a8162a36f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2183907dexchlorpheniramine maleate 2 MG in 5 mL Oral SolutionPSNaa4f80c9-e600-4bc0-8528-02a8162a36f02
2183912RyClora 2 MG in 5 mL Oral SolutionPSNaa4f80c9-e600-4bc0-8528-02a8162a36f02
2183912dexchlorpheniramine maleate 0.4 MG/ML Oral Solution [Ryclora]SBDaa4f80c9-e600-4bc0-8528-02a8162a36f02
2183907dexchlorpheniramine maleate 0.4 MG/ML Oral SolutionSCDaa4f80c9-e600-4bc0-8528-02a8162a36f02
2183907dexchlorpheniramine 2 MG per 5 ML Oral SolutionSYaa4f80c9-e600-4bc0-8528-02a8162a36f02
2183912Ryclora 0.4 MG/ML Oral SolutionSYaa4f80c9-e600-4bc0-8528-02a8162a36f02
2183912Ryclora 2 MG per ML Oral SolutionSYaa4f80c9-e600-4bc0-8528-02a8162a36f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15370-150-0415370015004118 mL in 1 BOTTLE, PLASTIC (15370-150-04) 118 ml2018-10-070000-00-00NoNoCurrent
15370-150-1615370015016473 mL in 1 BOTTLE, PLASTIC (15370-150-16) 473 ml2018-10-070000-00-00NoNoCurrent
15370-150-991537001509920 mL in 1 BOTTLE, PLASTIC (15370-150-99) 20 ml2018-10-070000-00-00NoNoCurrent