FDA.reportPublic FDA data

Guaifenesin

Product NDC
0363-0033
11-digit product format
003630033
Labeler code
0363
Product ID
0363-0033_e5e90576-743d-4e41-8b6e-efa7fb5c9e4c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA210453
Marketing category
ANDA
Marketing start
2020-05-08
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

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
0363-0033-01Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE17
0363-0033-01Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE147
0363-0033-02Guaifenesin2 in 1 CARTONTABLET, EXTENDED RELEASE27
0363-0033-02Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE147
0363-0033-03Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE147
0363-0033-03Guaifenesin3 in 1 CARTONTABLET, EXTENDED RELEASE37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0033GUAIFENESIN TABLET, EXTENDED RELEASE [WALGREEN CO.]6Current NDC, Legacy NDC, 6 package rows20231202_0c329d9f-8f1e-4b41-a03b-324e5d1b4ae2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN0c329d9f-8f1e-4b41-a03b-324e5d1b4ae27
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD0c329d9f-8f1e-4b41-a03b-324e5d1b4ae27
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY0c329d9f-8f1e-4b41-a03b-324e5d1b4ae27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0033-01003630033011 BLISTER PACK in 1 CARTON (0363-0033-01) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2020-05-080000-00-00NoNoCurrent
0363-0033-02003630033022 BLISTER PACK in 1 CARTON (0363-0033-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2020-05-080000-00-00NoNoCurrent
0363-0033-03003630033033 BLISTER PACK in 1 CARTON (0363-0033-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2021-04-010000-00-00NoNoCurrent