Clomipramine Hydrochloride NDC 16714-850

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-850Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0850Add 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
16714-850-01	16714085001	30 CAPSULE in 1 BOTTLE (16714-850-01)Marketed from Aug 27, 2018
16714-850-02	16714085002	90 CAPSULE in 1 BOTTLE (16714-850-02)Marketed from Aug 27, 2018
16714-850-03	16714085003	100 CAPSULE in 1 BOTTLE (16714-850-03)Marketed from Aug 27, 2018

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): Clomipramine Hydrochloride
Generic name (nonproprietary): clomipramine hydrochloride
Active ingredients: Clomipramine hydrochloride — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Northstar Rx LLC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208961
Marketing start: Aug 27, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 16714-850_57601a94-de02-4050-bbcf-fd7e6ac25825SPL ID 57601a94-de02-4050-bbcf-fd7e6ac25825SPL set ID b1809cb2-c6a8-451a-b692-506456c4efc3RxCUI 857297, 857301, 857305UNII 2LXW0L6GWJ
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

N416714085001 followed by a unit qualifier and the quantity

Package 16714-0850-01. 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 24, 2022. 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 1,989) 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208961

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

FDA NDC Directory listings under ANDA 208961
Product	Strength	Form · route	Labeler	Product NDC
Clomipramine Hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	Northstar Rx LLC.	16714-849
Clomipramine Hydrochloride	Clomipramine hydrochloride 75 mg/1	CapsuleOral	Northstar Rx LLC.	16714-851