Prescription drug · ANDA

Clomipramine Hydrochloride NDC 51672-4013

Clomipramine hydrochloride 75 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51672-4013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-4013Add 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 NDC11-digit (billing)PackageCopy
51672-4013-151672401301100 CAPSULE in 1 BOTTLE (51672-4013-1)Marketed from Dec 31, 1996
51672-4013-45167240130460 CAPSULE in 1 BOTTLE (51672-4013-4)Marketed from Dec 31, 1996
51672-4013-55167240130590 CAPSULE in 1 BOTTLE (51672-4013-5)Marketed from Dec 31, 1996
51672-4013-65167240130630 CAPSULE in 1 BOTTLE (51672-4013-6)Marketed from Dec 31, 1996

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074694
Marketing start
Listing expires
Identifiers
Product ID 51672-4013_34699b9e-d070-64b2-e063-6294a90a0f6dSPL ID 34699b9e-d070-64b2-e063-6294a90a0f6dSPL set ID db752dbd-be41-4cdd-8a13-ed1ff9ef7461RxCUI 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

N451672401301 followed by a unit qualifier and the quantity

Package 51672-4013-01. 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 . 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 ANDA 074694

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

FDA NDC Directory listings under ANDA 074694
ProductStrengthForm · routeLabelerProduct NDC
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-757
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-758
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-759
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4011
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4012
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralAmerican Health Packaging68084-790
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralAmerican Health Packaging68084-818
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralMajor Pharmaceuticals0904-7038
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralMajor Pharmaceuticals0904-7039

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Clomipramine Hydrochloride NDC 51672-4013 | Med-Code