NDC codes

FDA NDC Directory
Product NDC (as listed)0406-8807Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-8807Add 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
0406-8807-010040688070100406880701100 CAPSULE in 1 BOTTLE (0406-8807-01)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 — 50 mg/1
Dosage form
Capsule
Route
Oral
Labeler
SpecGx LLCNDC labeler code 0406
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 019906
Marketing start
Listing expires
Identifiers
Product ID 0406-8807_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

N400406880701 followed by a unit qualifier and the quantity

Package 00406-8807-01. 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)

About NDC 0406-8807

What is NDC 0406-8807?
0406-8807 is the product NDC for Clomipramine Hydrochloride, Clomipramine hydrochloride 50 mg/1 capsule, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clomipramine Hydrochloride.
What is the active ingredient?
Clomipramine hydrochloride.
Who is the labeler?
SpecGx LLC, NDC labeler code 0406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clomipramine Hydrochloride?
45 other product NDCs are listed under this name. See all Clomipramine Hydrochloride 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 Clomipramine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralAurobindo Pharma Limited59651-38359651-0383-0159651-0383-3059651-0383-90
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-40746708-0407-3046708-0407-3146708-0407-90
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-40846708-0408-3046708-0408-3146708-0408-90
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-40946708-0409-3046708-0409-3146708-0409-90
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-40762332-0407-3062332-0407-3162332-0407-90
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-40862332-0408-3062332-0408-3162332-0408-90
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-40962332-0409-3062332-0409-3162332-0409-90
Clomipramine hydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralAjanta Pharma USA Inc.27241-21027241-0210-0127241-0210-30
Clomipramine hydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralAjanta Pharma USA Inc.27241-21127241-0211-0127241-0211-30
Clomipramine hydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralAjanta Pharma USA Inc.27241-21227241-0212-0127241-0212-30

All 46 Clomipramine Hydrochloride NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Anafranilclomipramine hydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralSpecGx LLC0406-9906
Anafranilclomipramine hydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralSpecGx LLC0406-9907
Anafranilclomipramine hydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralSpecGx LLC0406-9908
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralSpecGx LLC0406-8806
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralSpecGx LLC0406-8808

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