FDA.reportPublic FDA data

Guaifenesin Extended-Release 600 mg

Product NDC
53041-233
11-digit product format
530410233
Labeler code
53041
Product ID
53041-233_8186c3e8-1ae5-459d-8771-ad2d1ae95387
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Guardian Drug Company
Application
ANDA209215
Marketing category
ANDA
Marketing start
2018-03-01
Substance
GUAIFENESIN
Active strength
600 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin Extended-Release 600 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621, 636522

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
53041-233-30Guaifenesin Extended-Release 600 mg1 in 1 CARTONTABLET, EXTENDED RELEASE12
53041-233-30Guaifenesin Extended-Release 600 mg10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
53041-233-32Guaifenesin Extended-Release 600 mg10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
53041-233-32Guaifenesin Extended-Release 600 mg2 in 1 CARTONTABLET, EXTENDED RELEASE22
53041-233-38Guaifenesin Extended-Release 600 mg4 in 1 CARTONTABLET, EXTENDED RELEASE42
53041-233-38Guaifenesin Extended-Release 600 mg10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-233GUAIFENESIN EXTENDED-RELEASE 600 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE GUAIFENESIN EXTENDED-RELEASE 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [GUARDIAN DRUG COMPANY]2Current NDC, Legacy NDC, 6 package rows20180301_20f9e083-419d-429d-a570-24b312ed5d2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN20f9e083-419d-429d-a570-24b312ed5d2a2
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN20f9e083-419d-429d-a570-24b312ed5d2a2
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD20f9e083-419d-429d-a570-24b312ed5d2a2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD20f9e083-419d-429d-a570-24b312ed5d2a2
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY20f9e083-419d-429d-a570-24b312ed5d2a2
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY20f9e083-419d-429d-a570-24b312ed5d2a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-233-30530410233301 BLISTER PACK in 1 CARTON (53041-233-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2018-03-010000-00-00NoNoCurrent
53041-233-32530410233322 BLISTER PACK in 1 CARTON (53041-233-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2018-03-010000-00-00NoNoCurrent
53041-233-38530410233384 BLISTER PACK in 1 CARTON (53041-233-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2018-03-010000-00-00NoNoCurrent