Prescription drug · ANDA
lofexidine hydrochloride NDC 72205-246
Lofexidine hydrochloride .2 mg/1 · Tablet, Film coated · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-246-42 | 7220502464272205024642 | 1 BOTTLE in 1 CARTON (72205-246-42) / 36 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 1, 2025 | |
| 72205-246-43 | 7220502464372205024643 | 1 BOTTLE in 1 CARTON (72205-246-43) / 96 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 1, 2025 |
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 hydrochloride
- Generic name (nonproprietary)
- lofexidine hydrochloride
- Active ingredients
- Lofexidine hydrochloride — .2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLCNDC labeler code 72205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218699
- Marketing start
- Listing expires
- Identifiers
- Product ID 72205-246_19b5c932-af2d-4a0b-ac4a-ba06c53c3219SPL ID 19b5c932-af2d-4a0b-ac4a-ba06c53c3219SPL set ID 19b5c932-af2d-4a0b-ac4a-ba06c53c3219RxCUI 2046591UNII V47G1SDI1BUPC 0372205246430, 0372205246423
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
N472205024642followed by a unit qualifier and the quantityPackage 72205-0246-42. 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 72205-246
- What is NDC 72205-246?
- 72205-246 is the product NDC for lofexidine hydrochloride, Lofexidine hydrochloride .2 mg/1 tablet, film coated, listed with the FDA by Novadoz Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- lofexidine hydrochloride.
- What is the active ingredient?
- Lofexidine hydrochloride.
- Who is the labeler?
- Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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 hydrochloride?
- 1 other product NDC are listed under this name. See all lofexidine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other lofexidine hydrochloride 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 hydrochloride | Lofexidine hydrochloride .2 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-345 | 66993-0345-3766993-0345-76 |