FDA.reportPublic FDA data

GUAIFENESIN

Product NDC
82804-265
11-digit product format
828040265
Labeler code
82804
Product ID
82804-265_28b31f37-6896-40f5-8f3a-60c93c5c1278
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA213420
Marketing category
ANDA
Marketing start
2022-08-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GUAIFENESIN
Listing expiration
2027-12-31

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
82804-265-20GUAIFENESIN20 in 1 BOTTLETABLET, EXTENDED RELEASE201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN28b31f37-6896-40f5-8f3a-60c93c5c12781
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD28b31f37-6896-40f5-8f3a-60c93c5c12781
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY28b31f37-6896-40f5-8f3a-60c93c5c12781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-265-208280402652020 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-265-20) 2026-02-02NoNoCurrent