FDA.reportPublic FDA data

Topcare mucus er

Product NDC
76162-123
11-digit product format
761620123
Labeler code
76162
Product ID
76162-123_e0a05c1e-af6d-4d2d-9d0e-80f1821f5266
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA078912
Marketing category
ANDA
Marketing start
2022-09-29
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
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
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-123-58Topcare mucus er1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL13
76162-123-58Topcare mucus er40 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL403
76162-123-60Topcare mucus er1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL13
76162-123-60Topcare mucus er20 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-123TOPCARE MUCUS ER (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 4 package rows20241215_e3c900ad-21b1-4cd0-8c48-f54f115df403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe3c900ad-21b1-4cd0-8c48-f54f115df4033
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe3c900ad-21b1-4cd0-8c48-f54f115df4033
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe3c900ad-21b1-4cd0-8c48-f54f115df4033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-123-58761620123581 BOTTLE in 1 CARTON (76162-123-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2022-09-290000-00-00NoNoCurrent
76162-123-60761620123601 BOTTLE in 1 CARTON (76162-123-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-11-04NoNoCurrent