lucemyra

Generic: lofexidine hydrochloride

Labeler: uswm, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lucemyra
Generic Name lofexidine hydrochloride
Labeler uswm, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lofexidine hydrochloride .2 mg/1

Manufacturer
USWM, LLC

Identifiers & Regulatory

Product NDC 78670-050
Product ID 78670-050_0be33ddd-71d6-45b7-85ce-e665789911ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209229
Marketing Start 2021-02-09
Marketing End 2026-08-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78670050
Hyphenated Format 78670-050

Supplemental Identifiers

RxCUI
2046591 2046597
UNII
V47G1SDI1B

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 lucemyra (source: ndc)
Generic Name lofexidine hydrochloride (source: ndc)
Application Number NDA209229 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .2 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (78670-050-03) / 36 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (78670-050-36) / 36 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (78670-050-96) / 96 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

78670-050-03 1 BOTTLE in 1 CARTON (78670-050-03) / 36 TABLET, FILM COATED in 1 BOTTLE 78670-050-36 1 BOTTLE in 1 CARTON (78670-050-36) / 36 TABLET, FILM COATED in 1 BOTTLE 78670-050-96 1 BOTTLE in 1 CARTON (78670-050-96) / 96 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

lofexidine hydrochloride (.2 mg/1)

Linked Drug Pages (1)

Lucemyra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0be33ddd-71d6-45b7-85ce-e665789911ba", "openfda": {"unii": ["V47G1SDI1B"], "rxcui": ["2046591", "2046597"], "spl_set_id": ["b748f308-ba71-4fd9-84ec-ec7e0f210885"], "manufacturer_name": ["USWM, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (78670-050-03)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "78670-050-03", "marketing_end_date": "20260831", "marketing_start_date": "20210209"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (78670-050-36)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "78670-050-36", "marketing_end_date": "20260831", "marketing_start_date": "20210209"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (78670-050-96)  / 96 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "78670-050-96", "marketing_end_date": "20260831", "marketing_start_date": "20210209"}], "brand_name": "Lucemyra", "product_id": "78670-050_0be33ddd-71d6-45b7-85ce-e665789911ba", "dosage_form": "TABLET, FILM COATED", "product_ndc": "78670-050", "generic_name": "lofexidine hydrochloride", "labeler_name": "USWM, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lucemyra", "active_ingredients": [{"name": "LOFEXIDINE HYDROCHLORIDE", "strength": ".2 mg/1"}], "application_number": "NDA209229", "marketing_category": "NDA", "marketing_end_date": "20260831", "marketing_start_date": "20210209"}