Clomipramine Hydrochloride NDC 59651-383

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-383Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0383Add 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
59651-383-01	59651038301	100 CAPSULE in 1 BOTTLE (59651-383-01)Marketed from Mar 20, 2023
59651-383-30	59651038330	30 CAPSULE in 1 BOTTLE (59651-383-30)Marketed from Mar 20, 2023
59651-383-90	59651038390	90 CAPSULE in 1 BOTTLE (59651-383-90)Marketed from Mar 20, 2023

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 — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216440
Marketing start: Mar 20, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 59651-383_7d11010e-cf0f-4315-aced-7927a486a1efSPL ID 7d11010e-cf0f-4315-aced-7927a486a1efSPL set ID 7d11010e-cf0f-4315-aced-7927a486a1efRxCUI 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

N459651038301 followed by a unit qualifier and the quantity

Package 59651-0383-01. 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 Mar 21, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clomipramine hydrochloride capsules 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 clomi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216440

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

FDA NDC Directory listings under ANDA 216440
Product	Strength	Form · route	Labeler	Product NDC
Clomipramine Hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-381
Clomipramine Hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-382