Rugby Mucus Relief ER

Product NDC
0536-1451
11-digit product format
005361451
Labeler code
0536
Product ID
0536-1451_630ac8f9-2489-473e-8607-47c49864cf6b
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA078912
Marketing category
ANDA
Marketing start
2025-06-17
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
Rugby Mucus Relief ER
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
0536-1451-88Rugby Mucus Relief ER2 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL22
0536-1451-88Rugby Mucus Relief ER7 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1451-88EA - Each0536-1451bf886e3f-5f12-4ff2-8529-5a8b5e25f52312025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN1c579aea-c9c5-44d0-997b-f350f84ac6d02
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD1c579aea-c9c5-44d0-997b-f350f84ac6d02
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY1c579aea-c9c5-44d0-997b-f350f84ac6d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1451-88005361451882 BLISTER PACK in 1 CARTON (0536-1451-88) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-06-17NoNoHistorical