guaifenesin extended-release

Generic: guaifenesin

Labeler: precision dose inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin extended-release
Generic Name guaifenesin
Labeler precision dose inc.
Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 600 mg/1

Manufacturer
Precision Dose Inc.

Identifiers & Regulatory

Product NDC 68094-048
Product ID 68094-048_9147ee25-d849-468c-a83d-7b413539c487
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078912
Listing Expiration 2026-12-31
Marketing Start 2023-03-22

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 68094048
Hyphenated Format 68094-048

Supplemental Identifiers

RxCUI
636522
UPC
0368094048613
UNII
495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 extended-release (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA078912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (68094-048-61) / 10 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK (68094-048-59)
source: ndc

Packages (1)

68094-048-61 10 BLISTER PACK in 1 CARTON (68094-048-61) / 10 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK (68094-048-59)

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Guaifenesin Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9147ee25-d849-468c-a83d-7b413539c487", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0368094048613"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["608b00c5-a2c7-4514-9b46-02954d6675d6"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Precision Dose Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68094-048-61)  / 10 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK (68094-048-59)", "package_ndc": "68094-048-61", "marketing_start_date": "20230322"}], "brand_name": "Guaifenesin Extended-Release", "product_id": "68094-048_9147ee25-d849-468c-a83d-7b413539c487", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "68094-048", "generic_name": "Guaifenesin", "labeler_name": "Precision Dose Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin Extended-Release", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA078912", "marketing_category": "ANDA", "marketing_start_date": "20230322", "listing_expiration_date": "20261231"}