guaifenesin and dextromethorphan hbr

Generic: guaifenesin and dextromethorphan hbr

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin and dextromethorphan hbr
Generic Name guaifenesin and dextromethorphan hbr
Labeler aurohealth llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 60 mg/1, guaifenesin 1200 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-849
Product ID 58602-849_72b8f474-79ca-4eaf-a036-8596d9ee9b2f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206941
Listing Expiration 2027-12-31
Marketing Start 2020-05-16

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 58602849
Hyphenated Format 58602-849

Supplemental Identifiers

RxCUI
1099074
UPC
0358602849658
UNII
9D2RTI9KYH 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 dextromethorphan hbr (source: ndc)
Generic Name guaifenesin and dextromethorphan hbr (source: ndc)
Application Number ANDA206941 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
  • 1200 mg/1
source: ndc
Packaging
  • 8 BLISTER PACK in 1 CARTON (58602-849-11) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (58602-849-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-849-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BLISTER PACK in 1 CARTON (58602-849-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (58602-849-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (5)

58602-849-11 8 BLISTER PACK in 1 CARTON (58602-849-11) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-849-15 1 BOTTLE in 1 CARTON (58602-849-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-849-57 1 BOTTLE in 1 CARTON (58602-849-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE 58602-849-64 1 BLISTER PACK in 1 CARTON (58602-849-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-849-65 2 BLISTER PACK in 1 CARTON (58602-849-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (60 mg/1) guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Guaifenesin and Dextromethorphan HBr ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "72b8f474-79ca-4eaf-a036-8596d9ee9b2f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0358602849658"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["88bc399a-2b71-45a7-bdfb-226ff1df0536"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 BLISTER PACK in 1 CARTON (58602-849-11)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-849-11", "marketing_start_date": "20200813"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-849-15)  / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-849-15", "marketing_start_date": "20200813"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-849-57)  / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "58602-849-57", "marketing_start_date": "20200908"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-849-64)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-849-64", "marketing_start_date": "20210224"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-849-65)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-849-65", "marketing_start_date": "20200516"}], "brand_name": "Guaifenesin and Dextromethorphan HBr", "product_id": "58602-849_72b8f474-79ca-4eaf-a036-8596d9ee9b2f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "58602-849", "generic_name": "Guaifenesin and Dextromethorphan HBr", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Dextromethorphan HBr", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA206941", "marketing_category": "ANDA", "marketing_start_date": "20200516", "listing_expiration_date": "20271231"}