FDA.reportPublic FDA data

GUAIFENESIN

Product NDC
70010-199
11-digit product format
700100199
Labeler code
70010
Product ID
70010-199_1cba14de-cac6-e5f3-e063-6294a90ab154
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
GRANULES PHARMACEUTICALS INC.
Application
ANDA213420
Marketing category
ANDA
Marketing start
2022-08-19
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

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
70010-199-05GUAIFENESIN500 in 1 BOTTLETABLET, EXTENDED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-199-05EA - Each70010-199dce956c0-6d27-41de-8ac1-f888d4d6e8f012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-199GUAIFENESIN TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 1 package rows20230129_e6994e38-2a21-4bcf-e053-2995a90a0854.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe6994e38-2a21-4bcf-e053-2995a90a08543
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe6994e38-2a21-4bcf-e053-2995a90a08543
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe6994e38-2a21-4bcf-e053-2995a90a08543
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN28b31f37-6896-40f5-8f3a-60c93c5c12781
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD28b31f37-6896-40f5-8f3a-60c93c5c12781
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY28b31f37-6896-40f5-8f3a-60c93c5c12781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-199-0570010019905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-199-05) 2022-08-190000-00-00NoNoCurrent