Prescription drug · ANDA
Clomipramine Hydrochloride (clomipramine hydrochloride capsules) NDC 68180-494
Clomipramine hydrochloride 75 mg/1 · Capsule · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-494-01 | 68180049401 | 100 CAPSULE in 1 BOTTLE (68180-494-01)Marketed from Feb 4, 2019 |
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 capsules
- Active ingredients
- Clomipramine hydrochloride — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209294
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-494_7e89336a-0de0-42d6-af70-26345940b81dSPL ID 7e89336a-0de0-42d6-af70-26345940b81dSPL set ID ebad19b5-e5dd-4f77-ab97-d20ce0f24cb9RxCUI 857297, 857301, 857305UNII 2LXW0L6GWJUPC 0368180494065, 0368180493068
- 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
N468180049401followed by a unit qualifier and the quantityPackage 68180-0494-01. 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 is 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 c…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209294
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clomipramine Hydrochlorideclomipramine hydrochloride capsules | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-493 |
| Clomipramine Hydrochlorideclomipramine hydrochloride capsules | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-492 |