Prescription drug · NDA
Lofexidine (Lofexidine hydrochloride) NDC 85789-901
Lofexidine hydrochloride .2 mg/1 · Tablet, Film coated · Oral · BioCorRx Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85789-901-36 | 85789090136 | 36 TABLET, FILM COATED in 1 BOTTLE (85789-901-36)Marketed from Aug 15, 2026 | |
| 85789-901-96 | 85789090196 | 96 TABLET, FILM COATED in 1 BOTTLE (85789-901-96)Marketed from Aug 15, 2026 |
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)
- Lofexidine
- Generic name (nonproprietary)
- lofexidine hydrochloride
- Active ingredients
- Lofexidine hydrochloride — .2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- BioCorRx Pharmaceuticals IncNDC labeler code 85789
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209229
- Marketing start
- Listing expires
- Identifiers
- Product ID 85789-901_6fe500eb-c442-4dd5-8d38-7568028628d3SPL ID 6fe500eb-c442-4dd5-8d38-7568028628d3SPL set ID 2dcc8288-adbe-45c3-b7bd-4d274001332dRxCUI 2046591UNII V47G1SDI1BUPC 0385789901961
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
N485789090136followed by a unit qualifier and the quantityPackage 85789-0901-36. 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)
Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. Lofexidine tablets are 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 85789-901
- What is NDC 85789-901?
- 85789-901 is the product NDC for Lofexidine (lofexidine hydrochloride), Lofexidine hydrochloride .2 mg/1 tablet, film coated, listed with the FDA by BioCorRx Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lofexidine (Lofexidine hydrochloride).
- What is the active ingredient?
- Lofexidine hydrochloride.
- Who is the labeler?
- BioCorRx Pharmaceuticals Inc, NDC labeler code 85789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lofexidine?
- 3 other product NDCs are listed under this name. See all Lofexidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lofexidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lofexidine | Lofexidine hydrochloride .18 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-909 | 70954-0909-1070954-0909-20 |
| Lofexidine | Lofexidine hydrochloride .18 mg/1 | Tablet, CoatedOral | Indoco Remedies Limited | 14445-146 | 14445-0146-3614445-0146-96 |
| Lofexidine | Lofexidine hydrochloride .18 mg/1 | Tablet, CoatedOral | Florida Pharmaceutical Products, LLC | 71921-250 | 71921-0250-3671921-0250-96 |
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 |
|---|---|---|---|---|
| Lofexidine hydrochloride | Lofexidine hydrochloride .2 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-345 |
| Lucemyralofexidine hydrochloride | Lofexidine hydrochloride .2 mg/1 | Tablet, Film coatedOral | USWM, LLC | 78670-050 |
| Lucemyralofexidine hydrochloride | Lofexidine hydrochloride .2 mg/1 | Tablet, Film coatedOral | BioCorRx Pharmaceuticals Inc | 85789-801 |