Betr remedies chest congestion relief

Product NDC
80267-010
11-digit product format
802670010
Labeler code
80267
Product ID
80267-010_638390ce-4a25-459c-a475-12e079a1d67f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Live Betr LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2023-03-20
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
Betr remedies chest congestion relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

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
80267-010-74Betr remedies chest congestion relief1 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL11
80267-010-74Betr remedies chest congestion relief14 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80267-010BETR REMEDIES CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [LIVE BETR LLC]1Current NDC, 2 package rows20230329_638390ce-4a25-459c-a475-12e079a1d67f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN638390ce-4a25-459c-a475-12e079a1d67f1
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD638390ce-4a25-459c-a475-12e079a1d67f1
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY638390ce-4a25-459c-a475-12e079a1d67f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80267-010-748026700107414 BLISTER PACK in 1 CARTON (80267-010-74) / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK14 blister pack2023-03-20NoNoHistorical