crcle guaifenesin extended-release tablets, 600 mg (57483-270)

Drug Facts

Product Profile

Brand Name crcle guaifenesin extended-release tablets, 600 mg

Generic Name guaifenesin extended-release

Labeler innovus pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

guaifenesin 600 mg/1

Manufacturer

Innovus Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 57483-270

Product ID 57483-270_77d8fc95-d94b-42f5-97ae-b5ff59ef638b

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213420

Listing Expiration 2026-12-31

Marketing Start 2020-09-10

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 57483270

Hyphenated Format 57483-270

Supplemental Identifiers

RxCUI

310621 636522

UNII

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 crcle guaifenesin extended-release tablets, 600 mg (source: ndc)

Generic Name guaifenesin extended-release (source: ndc)

Application Number ANDA213420 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1

source: ndc

Packaging

5 BLISTER PACK in 1 CARTON (57483-270-01) / 20 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

57483-270-01 5 BLISTER PACK in 1 CARTON (57483-270-01) / 20 TABLET in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "77d8fc95-d94b-42f5-97ae-b5ff59ef638b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["bba4b91a-bea9-41be-9588-5fb1483c7d10"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Innovus Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (57483-270-01)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "57483-270-01", "marketing_start_date": "20230428"}], "brand_name": "Crcle Guaifenesin Extended-Release Tablets, 600 mg", "product_id": "57483-270_77d8fc95-d94b-42f5-97ae-b5ff59ef638b", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "57483-270", "generic_name": "Guaifenesin Extended-Release", "labeler_name": "Innovus Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Crcle Guaifenesin Extended-Release Tablets, 600 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20200910", "listing_expiration_date": "20261231"}