FDA.reportPublic FDA data

Topcare Mucus ER

Product NDC
76162-523
11-digit product format
761620523
Labeler code
76162
Product ID
76162-523_587dfac2-f276-4f77-a36e-69ad14331bf5
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2022-09-09
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Mucus ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

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
76162-523-01Topcare Mucus ER14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL143
76162-523-01Topcare Mucus ER2 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL23
76162-523-74Topcare Mucus ER14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL143
76162-523-74Topcare Mucus ER1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-523TOPCARE MUCUS ER (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]3Current NDC, 4 package rows20240925_916de841-b1eb-4f00-9e25-1d2e4ab0c6e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN916de841-b1eb-4f00-9e25-1d2e4ab0c6e93
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD916de841-b1eb-4f00-9e25-1d2e4ab0c6e93
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY916de841-b1eb-4f00-9e25-1d2e4ab0c6e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-523-01761620523011 BLISTER PACK in 1 CARTON (76162-523-01) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-09-09NoNoHistorical
76162-523-747616205237414 in 1 BLISTER PACKHistorical