FDA.reportPublic FDA data

GUAIFENESIN

Product NDC
62207-569
11-digit product format
622070569
Labeler code
62207
Product ID
62207-569_4146b360-2965-a394-e063-6294a90a79df
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules India Ltd
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-02-01
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, 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
62207-569-93GUAIFENESIN5 in 1 BOXTABLET, EXTENDED RELEASE56
62207-569-93GUAIFENESIN2000 in 1 POUCHTABLET, EXTENDED RELEASE20006
62207-569-99GUAIFENESIN4200 in 1 BAGTABLET, EXTENDED RELEASE42006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-569GUAIFENESIN TABLET, EXTENDED RELEASE [GRANULES INDIA LTD]5Current NDC, Legacy NDC, 3 package rows20230131_ba7c1e26-b7d0-4aea-e053-2a95a90a903e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNba7c1e26-b7d0-4aea-e053-2a95a90a903e6
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNba7c1e26-b7d0-4aea-e053-2a95a90a903e6
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDba7c1e26-b7d0-4aea-e053-2a95a90a903e6
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDba7c1e26-b7d0-4aea-e053-2a95a90a903e6
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYba7c1e26-b7d0-4aea-e053-2a95a90a903e6
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYba7c1e26-b7d0-4aea-e053-2a95a90a903e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-569-93622070569935 POUCH in 1 BOX (62207-569-93) / 2000 TABLET, EXTENDED RELEASE in 1 POUCH5 pouch2021-11-170000-00-00NoNoCurrent
62207-569-99622070569994200 TABLET, EXTENDED RELEASE in 1 BAG (62207-569-99) 2021-02-010000-00-00NoNoCurrent