guaifenesin d

Generic: guaifenesin and pseudoephedrine hydrochloride

Labeler: rugby laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin d
Generic Name guaifenesin and pseudoephedrine hydrochloride
Labeler rugby laboratories, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1, pseudoephedrine hydrochloride 60 mg/1

Manufacturer
RUGBY LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 0536-1333
Product ID 0536-1333_4f4c9058-ec1c-48d5-81df-56188b7ae803
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212542
Listing Expiration 2026-12-31
Marketing Start 2022-04-04

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361333
Hyphenated Format 0536-1333

Supplemental Identifiers

RxCUI
1305603
UNII
495W7451VQ 6V9V2RYJ8N
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name guaifenesin d (source: ndc)
Generic Name guaifenesin and pseudoephedrine hydrochloride (source: ndc)
Application Number ANDA212542 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0536-1333-21) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (0536-1333-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

0536-1333-21 1 BLISTER PACK in 1 CARTON (0536-1333-21) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 0536-1333-36 2 BLISTER PACK in 1 CARTON (0536-1333-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

guaifenesin (600 mg/1) pseudoephedrine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Guaifenesin D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4f4c9058-ec1c-48d5-81df-56188b7ae803", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1305603"], "spl_set_id": ["997946e6-eff0-4c15-8694-020a19c2d336"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RUGBY LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0536-1333-21)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1333-21", "marketing_start_date": "20220404"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0536-1333-36)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1333-36", "marketing_start_date": "20220404"}], "brand_name": "Guaifenesin D", "product_id": "0536-1333_4f4c9058-ec1c-48d5-81df-56188b7ae803", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0536-1333", "generic_name": "Guaifenesin and Pseudoephedrine Hydrochloride", "labeler_name": "RUGBY LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin D", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA212542", "marketing_category": "ANDA", "marketing_start_date": "20220404", "listing_expiration_date": "20261231"}