GUAIFENESIN

Product NDC
30142-961
11-digit product format
301420961
Labeler code
30142
Product ID
30142-961_5b667b46-235a-4d9c-aea1-0ec8286e3bbc
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Kroger Company
Application
ANDA209254
Marketing category
ANDA
Marketing start
2022-04-28
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-961-20301420961201 BLISTER PACK in 1 CARTON (30142-961-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-04-280000-00-00NoNoCurrent