FDA.reportPublic FDA data

Leader Cough

Product NDC
70000-0302
11-digit product format
700000302
Labeler code
70000
Product ID
70000-0302_c2af792f-30a1-4f16-8b10-1822d23df4ee
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA091135
Marketing category
ANDA
Marketing start
2017-06-06
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Cough
Brand name suffix
DM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0302-1Leader CoughDM89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE895
70000-0302-1Leader CoughDM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE15
70000-0302-2Leader CoughDM148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1485
70000-0302-2Leader CoughDM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0302-1ML - Milliliter70000-030248c1b543-e9b3-4ac2-a41d-c5aeb8bd79c012018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0302LEADER COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 4 package rows20210618_a07b70d0-3842-4ea6-abb4-95b4638d5e55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNa07b70d0-3842-4ea6-abb4-95b4638d5e555
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDa07b70d0-3842-4ea6-abb4-95b4638d5e555
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYa07b70d0-3842-4ea6-abb4-95b4638d5e555
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYa07b70d0-3842-4ea6-abb4-95b4638d5e555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0302-1700000302011 BOTTLE in 1 CARTON (70000-0302-1) / 89 mL in 1 BOTTLE1 bottle2017-06-060000-00-00NoNoCurrent
70000-0302-2700000302021 BOTTLE in 1 CARTON (70000-0302-2) / 148 mL in 1 BOTTLE1 bottle2026-04-08NoNoCurrent