FDA.reportPublic FDA data

Guaifenesin D

Product NDC
0536-1333
11-digit product format
005361333
Labeler code
0536
Product ID
0536-1333_5123ee03-a227-4e51-e063-6294a90ab1a0
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RUGBY LABORATORIES, INC.
Application
ANDA212542
Marketing category
ANDA
Marketing start
2022-04-04
Marketing end
2027-03-31
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
600; 60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin D

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 6V9V2RYJ8N
Rxcui1305603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1333-21Guaifenesin D1 in 1 CARTONTABLET, EXTENDED RELEASE15
0536-1333-21Guaifenesin D18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE185
0536-1333-36Guaifenesin D2 in 1 CARTONTABLET, EXTENDED RELEASE25
0536-1333-36Guaifenesin D18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1333-21EA - Each0536-1333baae4bc6-dcdf-4176-a19f-a6da8e36e5b812022-02-07
0536-1333-36EA - Each0536-1333d190c168-29a7-4d7d-8d15-c2534d10d76812022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1333GUAIFENESIN D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RUGBY LABORATORIES, INC.]4Current NDC, Legacy NDC, 4 package rows20220516_997946e6-eff0-4c15-8694-020a19c2d336.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN997946e6-eff0-4c15-8694-020a19c2d3365
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD997946e6-eff0-4c15-8694-020a19c2d3365
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY997946e6-eff0-4c15-8694-020a19c2d3365

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1333-21005361333211 BLISTER PACK in 1 CARTON (0536-1333-21) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-04-042027-03-31NoNoCurrent
0536-1333-36005361333362 BLISTER PACK in 1 CARTON (0536-1333-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2022-04-042027-03-31NoNoCurrent