guaifenesin and pseudoephedrine hcl

Generic: guaifenesin and pseudoephedrine hcl

Labeler: kroger company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin and pseudoephedrine hcl
Generic Name guaifenesin and pseudoephedrine hcl
Labeler kroger company
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
KROGER COMPANY

Identifiers & Regulatory

Product NDC 30142-137
Product ID 30142-137_bd1d5672-dce6-47dc-96be-26bce0db708d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213203
Listing Expiration 2026-12-31
Marketing Start 2021-04-16

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 30142137
Hyphenated Format 30142-137

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 and pseudoephedrine hcl (source: ndc)
Generic Name guaifenesin and pseudoephedrine hcl (source: ndc)
Application Number ANDA213203 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (30142-137-12) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (30142-137-17) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

Ingredients (2)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "bd1d5672-dce6-47dc-96be-26bce0db708d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1305603"], "spl_set_id": ["b97aeb2c-07ac-d00e-e053-2a95a90abf40"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["KROGER COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (30142-137-12)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "30142-137-12", "marketing_start_date": "20210416"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (30142-137-17)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "30142-137-17", "marketing_start_date": "20210416"}], "brand_name": "Guaifenesin and Pseudoephedrine HCl", "product_id": "30142-137_bd1d5672-dce6-47dc-96be-26bce0db708d", "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": "30142-137", "generic_name": "Guaifenesin and Pseudoephedrine HCl", "labeler_name": "KROGER COMPANY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Pseudoephedrine HCl", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA213203", "marketing_category": "ANDA", "marketing_start_date": "20210416", "listing_expiration_date": "20261231"}