guaifenesin and pseudoephedrine hcl (51660-077)

Drug Facts

Product Profile

Brand Name guaifenesin and pseudoephedrine hcl

Generic Name guaifenesin and pseudoephedrine hcl

Labeler ohm laboratories, inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 1200 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer

Ohm Laboratories, Inc.

Identifiers & Regulatory

Product NDC 51660-077

Product ID 51660-077_2522057d-9a67-f0f3-e063-6394a90af3f5

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA212542

Listing Expiration 2026-12-31

Marketing Start 2021-04-01

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 51660077

Hyphenated Format 51660-077

Supplemental Identifiers

RxCUI

1244675 1305603

UPC

0351660077124 0351660074185

UNII

6V9V2RYJ8N 495W7451VQ

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 ANDA212542 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1200 mg/1
120 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (51660-077-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

51660-077-12 1 BLISTER PACK in 1 CARTON (51660-077-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

guaifenesin (1200 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Guaifenesin and Pseudoephedrine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2522057d-9a67-f0f3-e063-6394a90af3f5", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0351660077124", "0351660074185"], "unii": ["6V9V2RYJ8N", "495W7451VQ"], "rxcui": ["1244675", "1305603"], "spl_set_id": ["2521ecd3-28f3-a13c-e063-6394a90a7245"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Ohm Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51660-077-12)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51660-077-12", "marketing_start_date": "20210401"}], "brand_name": "Guaifenesin and Pseudoephedrine HCl", "product_id": "51660-077_2522057d-9a67-f0f3-e063-6394a90af3f5", "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": "51660-077", "generic_name": "Guaifenesin and Pseudoephedrine HCl", "labeler_name": "Ohm Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Pseudoephedrine HCl", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA212542", "marketing_category": "ANDA", "marketing_start_date": "20210401", "listing_expiration_date": "20261231"}