GUAIFENESIN - ODAAT

Product NDC
83139-175
11-digit product format
831390175
Labeler code
83139
Product ID
83139-175_f61d3ae0-11ec-2a82-e053-2995a90a95da
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET
Route
ORAL
Labeler
LODAAT LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2023-03-04
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
GUAIFENESIN - ODAAT
Brand name suffix
1200 MG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83139-175-01GUAIFENESIN - ODAAT1200 MG100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83139-175GUAIFENESIN - ODAAT 1200 MG (GUAIFENESIN) TABLET [LODAAT LLC]1Current NDC, 1 package rows20230307_f61d3ae0-11eb-2a82-e053-2995a90a95da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNf61d3ae0-11eb-2a82-e053-2995a90a95da1
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDf61d3ae0-11eb-2a82-e053-2995a90a95da1
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYf61d3ae0-11eb-2a82-e053-2995a90a95da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83139-175-0183139017501100 TABLET in 1 BOTTLE (83139-175-01) 100 tablet2023-03-04NoNoCurrent