Leader Mucus Relief

Product NDC
70000-0758
11-digit product format
700000758
Labeler code
70000
Product ID
70000-0758_e2a1f2ff-1dd6-4505-b638-cf91bb93ee24
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA078912
Marketing category
ANDA
Marketing start
2026-04-08
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Mucus Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0758-1Leader Mucus Relief20 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL202
70000-0758-1Leader Mucus Relief1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNca735722-0baa-4c85-8311-17dbce915fc52
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDca735722-0baa-4c85-8311-17dbce915fc52
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYca735722-0baa-4c85-8311-17dbce915fc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0758-1700000758011 BLISTER PACK in 1 CARTON (70000-0758-1) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2026-04-08NoNoHistorical