Guaifenesin

Product NDC
11673-539
11-digit product format
116730539
Labeler code
11673
Product ID
11673-539_465357f3-c844-b291-e063-6394a90a3bf5
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
TARGET CORPORATION
Application
ANDA213420
Marketing category
ANDA
Marketing start
2024-08-01
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
Guaifenesin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

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
11673-539-02Guaifenesin20 in 1 BLISTER PACKTABLET206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-539GUAIFENESIN TABLET [TARGET CORPORATION]4Current NDC, 1 package rows20241226_0a0aa190-8dc7-f9cc-e063-6394a90a6078.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN0a0aa190-8dc7-f9cc-e063-6394a90a60786
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD0a0aa190-8dc7-f9cc-e063-6394a90a60786
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY0a0aa190-8dc7-f9cc-e063-6394a90a60786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-539-021167305390220 TABLET in 1 BLISTER PACK (11673-539-02) 20 tablet2024-08-01NoNoHistorical