What is NDC 14445-146?

14445-146 is the product NDC for Lofexidine, Lofexidine hydrochloride .18 mg/1 tablet, coated, listed with the FDA by Indoco Remedies Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Indoco Remedies Limited, NDC labeler code 14445. 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 14445-146 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)14445-146Labeler and product segments. Claims need a package NDC.

Product NDC at billing width14445-0146Add 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
14445-146-36	1444501463614445014636	1 BOTTLE in 1 CARTON (14445-146-36) / 36 TABLET, COATED in 1 BOTTLEMarketed from Aug 21, 2024
14445-146-96	1444501469614445014696	1 BOTTLE in 1 CARTON (14445-146-96) / 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: Indoco Remedies LimitedNDC labeler code 14445
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 14445-146_d60a5ecb-5e15-4ea7-bc53-a3740f00adffSPL ID d60a5ecb-5e15-4ea7-bc53-a3740f00adffSPL set ID ed7613f5-ac52-4108-afb7-d92c818d6e3cRxCUI 2046591UNII 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

N414445014636 followed by a unit qualifier and the quantity

Package 14445-0146-36. 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 Aug 21, 2024.

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 14445-146

What is NDC 14445-146?: 14445-146 is the product NDC for Lofexidine, Lofexidine hydrochloride .18 mg/1 tablet, coated, listed with the FDA by Indoco Remedies Limited. 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?: Indoco Remedies Limited, NDC labeler code 14445. 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	Florida Pharmaceutical Products, LLC	71921-250	71921-0250-3671921-0250-96

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	Florida Pharmaceutical Products, LLC	71921-250