Clomipramine Hydrochloride NDC 0406-8808

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-8808Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-8808Add 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
0406-8808-01	00406880801	100 CAPSULE in 1 BOTTLE (0406-8808-01)Marketed from Jun 1, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Clomipramine Hydrochloride
Generic name (nonproprietary): clomipramine hydrochloride
Active ingredients: Clomipramine hydrochloride — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019906
Marketing start: Jun 1, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 0406-8808_f7da2c91-cd58-46c3-b716-846a454cfb07SPL ID f7da2c91-cd58-46c3-b716-846a454cfb07SPL set ID d7cee3fa-d05c-4702-8f75-f446627bdb49RxCUI 857297, 857301, 857305UNII 2LXW0L6GWJUPC 0304068808012, 0304068807015, 0304068806018
Pharmacologic class: Tricyclic Antidepressant

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

N400406880801 followed by a unit qualifier and the quantity

Package 00406-8808-01. 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 Nov 26, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clomipramine Hydrochloride Capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019906

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

FDA NDC Directory listings under NDA 019906
Product	Strength	Form · route	Labeler	Product NDC
Clomipramine Hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	SpecGx LLC	0406-8806
Clomipramine Hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	SpecGx LLC	0406-8807
Anafranilclomipramine hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	SpecGx LLC	0406-9906
Anafranilclomipramine hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	SpecGx LLC	0406-9907
Anafranilclomipramine hydrochloride	Clomipramine hydrochloride 75 mg/1	CapsuleOral	SpecGx LLC	0406-9908