What is NDC 70954-909?

70954-909 is the product NDC for Lofexidine, Lofexidine hydrochloride .18 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 70954-909 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-909Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0909Add 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
70954-909-10	70954090910	36 TABLET in 1 BOTTLE (70954-909-10)Marketed from Oct 22, 2025
70954-909-20	70954090920	96 TABLET in 1 BOTTLE (70954-909-20)Marketed from Oct 22, 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
Generic name (nonproprietary): lofexidine
Active ingredients: Lofexidine hydrochloride — .18 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219917
Marketing start: Oct 22, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 70954-909_335e26bf-b236-46d6-81cf-2879e5f3b1d9SPL ID 335e26bf-b236-46d6-81cf-2879e5f3b1d9SPL set ID 335e26bf-b236-46d6-81cf-2879e5f3b1d9RxCUI 2046591UNII V47G1SDI1BUPC 0370954909200, 0370954909101

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

N470954090910 followed by a unit qualifier and the quantity

Package 70954-0909-10. 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 Sep 5, 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. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-909

What is NDC 70954-909?: 70954-909 is the product NDC for Lofexidine, Lofexidine hydrochloride .18 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. 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?: ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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	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