berkley and jensen mucus relief

Product NDC
68391-000
11-digit product format
683910000
Labeler code
68391
Product ID
68391-000_6792a293-6488-4eb4-adb6-0d8dbe93d4fc
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
BJWC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-04-04
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
berkley and jensen mucus 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
68391-000-45berkley and jensen mucus relief4 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL42
68391-000-45berkley and jensen mucus relief14 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-000BERKLEY AND JENSEN MUCUS RELIEF (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [BJWC]2Current NDC, Legacy NDC, 2 package rows20220618_433588eb-18ad-473f-9527-4947a143824e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN433588eb-18ad-473f-9527-4947a143824e2
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD433588eb-18ad-473f-9527-4947a143824e2
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY433588eb-18ad-473f-9527-4947a143824e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-000-45683910000454 BLISTER PACK in 1 CARTON (68391-000-45) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2021-04-040000-00-00NoNoCurrent