FDA.reportPublic FDA data

Guaifenesin Extended-Release

Product NDC
68094-048
11-digit product format
680940048
Labeler code
68094
Product ID
68094-048_9147ee25-d849-468c-a83d-7b413539c487
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA078912
Marketing category
ANDA
Marketing start
2023-03-22
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 Extended-Release
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
68094-048-59Guaifenesin Extended-Release10 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL103
68094-048-61Guaifenesin Extended-Release10 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-048-59EA - Each68094-048d0f4fa0d-d413-4fe0-838f-1d7512c9295712023-06-06
68094-048-61EA - Each68094-048802f3665-498b-44d8-ac74-625a850278ae12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-048GUAIFENESIN EXTENDED-RELEASE (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [PRECISION DOSE INC.]3Current NDC, 2 package rows20250529_608b00c5-a2c7-4514-9b46-02954d6675d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN608b00c5-a2c7-4514-9b46-02954d6675d63
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD608b00c5-a2c7-4514-9b46-02954d6675d63
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY608b00c5-a2c7-4514-9b46-02954d6675d63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-048-596809400485910 in 1 BLISTER PACKHistorical
68094-048-616809400486110 BLISTER PACK in 1 CARTON (68094-048-61) / 10 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK (68094-048-59) 10 blister pack2023-03-22NoNoHistorical