crcle guaifensin extended release tablet, 1200 mg

Generic: guaifensin extended-release

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name crcle guaifensin extended release tablet, 1200 mg
Generic Name guaifensin extended-release
Labeler innovus pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 1200 mg/1

Manufacturer
Innovus Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 57483-280
Product ID 57483-280_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 57483280
Hyphenated Format 57483-280

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 guaifensin extended release tablet, 1200 mg (source: ndc)
Generic Name guaifensin extended-release (source: ndc)
Application Number ANDA213420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (57483-280-02) / 14 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

57483-280-02 4 BLISTER PACK in 1 CARTON (57483-280-02) / 14 TABLET in 1 BLISTER PACK

Ingredients (1)

guaifenesin (1200 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": "4 BLISTER PACK in 1 CARTON (57483-280-02)  / 14 TABLET in 1 BLISTER PACK", "package_ndc": "57483-280-02", "marketing_start_date": "20230428"}], "brand_name": "Crcle Guaifensin Extended Release Tablet, 1200 mg", "product_id": "57483-280_77d8fc95-d94b-42f5-97ae-b5ff59ef638b", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "57483-280", "generic_name": "Guaifensin Extended-Release", "labeler_name": "Innovus Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Crcle Guaifensin Extended Release Tablet, 1200 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20200910", "listing_expiration_date": "20261231"}