FDA.reportPublic FDA data

Guaifenesin 600 mg

Product NDC
25000-042
11-digit product format
250000042
Labeler code
25000
Product ID
25000-042_0af3bdb4-c1f3-4941-a1de-6e08c49849cb
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin 600 mg
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA217780
Marketing category
ANDA
Marketing start
2023-08-23
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 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-042-01Guaifenesin 600 mg20 in 1 BOTTLETABLET206
25000-042-01Guaifenesin 600 mg1 in 1 CARTONTABLET16
25000-042-12Guaifenesin 600 mg500 in 1 BOTTLETABLET5006
25000-042-55Guaifenesin 600 mg2 in 1 CARTONTABLET26
25000-042-55Guaifenesin 600 mg10 in 1 BLISTER PACKTABLET106
25000-042-99Guaifenesin 600 mg2 in 1 CARTONTABLET26
25000-042-99Guaifenesin 600 mg20 in 1 BLISTER PACKTABLET206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-042GUAIFENESIN 600 MG TABLET GUAIFENESIN 1200 MG TABLET [MARKSANS PHARMA LIMITED]4Current NDC, 7 package rows20250426_fedf43d0-d6d1-4f50-bbab-396701e45cb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNfedf43d0-d6d1-4f50-bbab-396701e45cb26
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNfedf43d0-d6d1-4f50-bbab-396701e45cb26
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDfedf43d0-d6d1-4f50-bbab-396701e45cb26
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDfedf43d0-d6d1-4f50-bbab-396701e45cb26
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYfedf43d0-d6d1-4f50-bbab-396701e45cb26
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYfedf43d0-d6d1-4f50-bbab-396701e45cb26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25000-042-01250000042011 BOTTLE in 1 CARTON (25000-042-01) / 20 TABLET in 1 BOTTLE1 bottle2023-08-23NoNoCurrent
25000-042-1225000004212500 TABLET in 1 BOTTLE (25000-042-12) 500 tablet2023-08-23NoNoCurrent
25000-042-55250000042552 BLISTER PACK in 1 CARTON (25000-042-55) / 10 TABLET in 1 BLISTER PACK2 blister pack2023-08-23NoNoCurrent
25000-042-99250000042992 BLISTER PACK in 1 CARTON (25000-042-99) / 20 TABLET in 1 BLISTER PACK2 blister pack2025-04-18NoNoCurrent