NDC directory

Guaifenesin

INNOVUS PHARMACEUTICALS, INC. · TABLET, EXTENDED RELEASE

57483-144ANDADecreased Respiratory Secretion Viscosity [PE]
Product NDC
57483-144
Generic name
Guaifenesin
Labeler name
INNOVUS PHARMACEUTICALS, INC.
Brand name
Guaifenesin
Finished
true
Listing expiration date
20271231
Marketing category
ANDA
Dosage form
TABLET, EXTENDED RELEASE
SPL ID
f7682626-5c29-44af-a32d-3fa52e7f7482
Product type
HUMAN OTC DRUG
Marketing start date
20261027
Product ID
57483-144_f7682626-5c29-44af-a32d-3fa52e7f7482
Application number
ANDA210453
Brand name base
Guaifenesin
Active ingredients
  1. Name
    GUAIFENESIN
    Strength
    1200 mg/1
Packaging
  1. Package NDC
    57483-144-28
    Description
    2 BLISTER PACK in 1 CARTON (57483-144-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    Marketing start date
    20261027
    Sample
    false
Route
ORAL
Pharm class
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.