What is NDC 71921-250?

71921-250 is the product NDC for Lofexidine, Lofexidine hydrochloride .18 mg/1 tablet, coated, listed with the FDA by Florida Pharmaceutical Products, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Florida Pharmaceutical Products, LLC, NDC labeler code 71921. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lofexidine NDC 71921-250 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71921-250Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71921-0250Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71921-250-36	7192102503671921025036	1 BOTTLE in 1 CARTON (71921-250-36) / 36 TABLET, COATED in 1 BOTTLEMarketed from Aug 21, 2024
71921-250-96	7192102509671921025096	1 BOTTLE in 1 CARTON (71921-250-96) / 96 TABLET, COATED in 1 BOTTLEMarketed from Aug 21, 2024

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
Active ingredients: Lofexidine hydrochloride — .18 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Florida Pharmaceutical Products, LLCNDC labeler code 71921
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218613
Marketing start: Aug 21, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 71921-250_f742254f-781e-4e7a-ae0b-e79b8482980dSPL ID f742254f-781e-4e7a-ae0b-e79b8482980dSPL set ID ce4488e2-842c-45ba-aca7-075a900e2a1cRxCUI 2046591UNII V47G1SDI1BUPC 0371921250967

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

N471921025036 followed by a unit qualifier and the quantity

Package 71921-0250-36. 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 May 21, 2026.

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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71921-250

What is NDC 71921-250?: 71921-250 is the product NDC for Lofexidine, Lofexidine hydrochloride .18 mg/1 tablet, coated, listed with the FDA by Florida Pharmaceutical Products, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lofexidine.
What is the active ingredient?: Lofexidine hydrochloride.
Who is the labeler?: Florida Pharmaceutical Products, LLC, NDC labeler code 71921. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lofexidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lofexidinelofexidine hydrochloride	Lofexidine hydrochloride .2 mg/1	Tablet, Film coatedOral	BioCorRx Pharmaceuticals Inc	85789-901	85789-0901-3685789-0901-96
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

Other NDCs under ANDA 218613

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218613
Product	Strength	Form · route	Labeler	Product NDC
Lofexidine	Lofexidine hydrochloride .18 mg/1	Tablet, CoatedOral	Indoco Remedies Limited	14445-146