Prescription drug · ANDA
Clomipramine Hydrochloride NDC 59651-382
Clomipramine hydrochloride 50 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-382-01 | 59651038201 | 100 CAPSULE in 1 BOTTLE (59651-382-01)Marketed from Mar 20, 2023 | |
| 59651-382-30 | 59651038230 | 30 CAPSULE in 1 BOTTLE (59651-382-30)Marketed from Mar 20, 2023 | |
| 59651-382-90 | 59651038290 | 90 CAPSULE in 1 BOTTLE (59651-382-90)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 — 50 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
- Listing expires
- Identifiers
- Product ID 59651-382_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
N459651038201followed by a unit qualifier and the quantityPackage 59651-0382-01. 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 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.
Other NDCs under ANDA 216440
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 Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-381 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-383 |