What is NDC 66993-345?

66993-345 is the product NDC for Lofexidine hydrochloride, Lofexidine hydrochloride .2 mg/1 tablet, film coated, listed with the FDA by Prasco Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.

Prasco Laboratories, NDC labeler code 66993. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lofexidine hydrochloride NDC 66993-345

NDC codes

FDA NDC Directory

Product NDC (as listed)66993-345Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66993-0345Add 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
66993-345-37	6699303453766993034537	1 BOTTLE in 1 CARTON (66993-345-37) / 36 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 29, 2024
66993-345-76	6699303457666993034576	1 BOTTLE in 1 CARTON (66993-345-76) / 96 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 29, 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 hydrochloride
Generic name (nonproprietary): lofexidine hydrochloride
Active ingredients: Lofexidine hydrochloride — .2 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Prasco LaboratoriesNDC labeler code 66993
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 209229
Marketing start: Aug 29, 2024
Marketing end: Jun 30, 2027
Identifiers: Product ID 66993-345_bbbf56d0-44c9-4872-95ac-ebbef0eb5b79SPL ID bbbf56d0-44c9-4872-95ac-ebbef0eb5b79SPL set ID 77367dfa-434f-4d61-95fe-f0f1628457d1RxCUI 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

N466993034537 followed by a unit qualifier and the quantity

Package 66993-0345-37. 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 14, 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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66993-345

What is NDC 66993-345?: 66993-345 is the product NDC for Lofexidine hydrochloride, Lofexidine hydrochloride .2 mg/1 tablet, film coated, listed with the FDA by Prasco Laboratories. 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?: Prasco Laboratories, NDC labeler code 66993. 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.

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

Other Lofexidine hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
lofexidine hydrochloride	Lofexidine hydrochloride .2 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-246	72205-0246-4272205-0246-43

Other NDCs under NDA 209229

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

FDA NDC Directory listings under NDA 209229
Product	Strength	Form · route	Labeler	Product NDC
Lofexidinelofexidine hydrochloride	Lofexidine hydrochloride .2 mg/1	Tablet, Film coatedOral	BioCorRx Pharmaceuticals Inc	85789-901
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