Prescription drug · ANDA
Clomipramine Hydrochloride NDC 51672-4012
Clomipramine hydrochloride 50 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4012-1 | 51672401201 | 100 CAPSULE in 1 BOTTLE (51672-4012-1)Marketed from Dec 31, 1996 | |
| 51672-4012-4 | 51672401204 | 60 CAPSULE in 1 BOTTLE (51672-4012-4)Marketed from Dec 31, 1996 | |
| 51672-4012-5 | 51672401205 | 90 CAPSULE in 1 BOTTLE (51672-4012-5)Marketed from Dec 31, 1996 | |
| 51672-4012-6 | 51672401206 | 30 CAPSULE in 1 BOTTLE (51672-4012-6)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 — 50 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 51672-4012_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
N451672401201followed by a unit qualifier and the quantityPackage 51672-4012-01. 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.
Other NDCs under ANDA 074694
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 | Golden State Medical Supply, Inc. | 51407-757 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-758 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-759 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 51672-4011 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 51672-4013 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | American Health Packaging | 68084-790 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | American Health Packaging | 68084-818 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7038 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7039 |