Prescription drug · NDA
Lucemyra (Lofexidine hydrochloride) NDC 78670-050
Lofexidine hydrochloride .2 mg/1 · Tablet, Film coated · Oral · USWM, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78670-050-36 | 78670005036 | 1 BOTTLE in 1 CARTON (78670-050-36) / 36 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 9, 2021 | |
| 78670-050-96 | 78670005096 | 1 BOTTLE in 1 CARTON (78670-050-96) / 96 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 9, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lucemyra
- Generic name (nonproprietary)
- lofexidine hydrochloride
- Active ingredients
- Lofexidine hydrochloride — .2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- USWM, LLCNDC labeler code 78670
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209229
- Marketing start
- Marketing end
- Identifiers
- Product ID 78670-050_f8d66b8e-b466-41e4-a30f-03aaa9a2940fSPL ID f8d66b8e-b466-41e4-a30f-03aaa9a2940fSPL set ID b748f308-ba71-4fd9-84ec-ec7e0f210885RxCUI 2046591, 2046597UNII V47G1SDI1B
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N478670005036followed by a unit qualifier and the quantityPackage 78670-0050-36. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
LUCEMYRA is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. LUCEMYRA is a central alpha-2 adrenergic agonist indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 78670-050
- What is NDC 78670-050?
- 78670-050 is the product NDC for Lucemyra (lofexidine hydrochloride), Lofexidine hydrochloride .2 mg/1 tablet, film coated, listed with the FDA by USWM, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lucemyra (Lofexidine hydrochloride).
- What is the active ingredient?
- Lofexidine hydrochloride.
- Who is the labeler?
- USWM, LLC, NDC labeler code 78670. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lucemyra?
- 1 other product NDC are listed under this name. See all Lucemyra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lucemyra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lucemyralofexidine hydrochloride | Lofexidine hydrochloride .2 mg/1 | Tablet, Film coatedOral | BioCorRx Pharmaceuticals Inc | 85789-801 | 85789-0801-3685789-0801-96 |
Other NDCs under NDA 209229
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lofexidinelofexidine hydrochloride | Lofexidine hydrochloride .2 mg/1 | Tablet, Film coatedOral | BioCorRx Pharmaceuticals Inc | 85789-901 |
| Lofexidine hydrochloride | Lofexidine hydrochloride .2 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-345 |
| Lucemyralofexidine hydrochloride | Lofexidine hydrochloride .2 mg/1 | Tablet, Film coatedOral | BioCorRx Pharmaceuticals Inc | 85789-801 |