FDA.reportPublic FDA data

Mucus Relief Extended Release

Product NDC
70000-0479
11-digit product format
700000479
Labeler code
70000
Product ID
70000-0479_df386042-7796-4e24-9f8e-39ea465065ad
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application
ANDA207342
Marketing category
ANDA
Marketing start
2019-01-31
Marketing end
2027-03-28
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief Extended Release
Brand name suffix
Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

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
70000-0479-1Mucus Relief Extended ReleaseMaximum Strength14 in 1 CARTONTABLET146
70000-0479-1Mucus Relief Extended ReleaseMaximum Strength1 in 1 BLISTER PACKTABLET16
70000-0479-2Mucus Relief Extended ReleaseMaximum Strength1 in 1 BLISTER PACKTABLET16
70000-0479-2Mucus Relief Extended ReleaseMaximum Strength28 in 1 CARTONTABLET286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0479-1EA - Each70000-0479aa64d1e2-ff17-40f6-bee0-1a1e857848ee12019-08-06
70000-0479-2EA - Each70000-047995b9120a-15d5-4de2-aa4b-8e223126c30312019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0479MUCUS RELIEF EXTENDED RELEASE MAXIMUM STRENGTH (GUAIFENESIN) TABLET [CARDINAL HEALTH (LEADER) 70000]5Current NDC, Legacy NDC, 4 package rows20221021_54a59e95-f95a-4bcd-ac9d-8d4ace85277f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN54a59e95-f95a-4bcd-ac9d-8d4ace85277f6
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD54a59e95-f95a-4bcd-ac9d-8d4ace85277f6
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY54a59e95-f95a-4bcd-ac9d-8d4ace85277f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0479-17000004790114 BLISTER PACK in 1 CARTON (70000-0479-1) / 1 TABLET in 1 BLISTER PACK14 blister pack2019-01-312026-10-28NoNoCurrent
70000-0479-27000004790228 BLISTER PACK in 1 CARTON (70000-0479-2) / 1 TABLET in 1 BLISTER PACK28 blister pack2019-01-312027-03-28NoNoCurrent