EXPECTORANT GUAIFENESIN EXTENDED-RELEASE

Product NDC
81179-007
11-digit product format
811790007
Labeler code
81179
Product ID
81179-007_0e127c48-e134-a961-e063-6394a90a3174
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET
Route
ORAL
Labeler
YET HEALTH GROUP LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-04-05
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
EXPECTORANT GUAIFENESIN EXTENDED-RELEASE
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
81179-007-04EXPECTORANT GUAIFENESIN EXTENDED-RELEASE14 in 1 BLISTER PACKTABLET145
81179-007-04EXPECTORANT GUAIFENESIN EXTENDED-RELEASE5 in 1 PACKAGETABLET55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81179-007EXPECTORANT GUAIFENESIN EXTENDED-RELEASE (GUAIFENESIN) TABLET [YET HEALTH GROUP LLC]5Current NDC, Legacy NDC, 2 package rows20240104_f863ab35-046b-4006-901e-dd290c164acc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNf863ab35-046b-4006-901e-dd290c164acc5
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDf863ab35-046b-4006-901e-dd290c164acc5
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYf863ab35-046b-4006-901e-dd290c164acc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81179-007-04811790007045 BLISTER PACK in 1 PACKAGE (81179-007-04) / 14 TABLET in 1 BLISTER PACK5 blister pack2021-04-120000-00-00NoNoCurrent