FDA.reportPublic FDA data

Maximum Strength Mucus Relief

Product NDC
63868-148
11-digit product format
638680148
Labeler code
63868
Product ID
63868-148_2435d335-106c-2322-e063-6394a90a1b26
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-09-17
Marketing end
2027-02-28
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
Maximum Strength Mucus Relief

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
63868-148-14Maximum Strength Mucus Relief2 in 1 CARTONTABLET, EXTENDED RELEASE23
63868-148-14Maximum Strength Mucus Relief7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-148-14EA - Each63868-1483421f92b-d10f-49cb-bb4b-f96827a5082512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-148MAXIMUM STRENGTH MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]3Current NDC, Legacy NDC, 2 package rows20241013_c20f64e3-485b-4ea7-b73d-56e5c898ed2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNc20f64e3-485b-4ea7-b73d-56e5c898ed2e3
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDc20f64e3-485b-4ea7-b73d-56e5c898ed2e3
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYc20f64e3-485b-4ea7-b73d-56e5c898ed2e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-148-14638680148142 BLISTER PACK in 1 CARTON (63868-148-14) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2021-09-172027-02-28NoNoCurrent