Prescription drug · ANDA
Clomipramine Hydrochloride NDC 71205-910
Clomipramine hydrochloride 25 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-910-00 | 71205091000 | 100 CAPSULE in 1 BOTTLE (71205-910-00)Marketed from Jul 16, 2021 | |
| 71205-910-11 | 71205091011 | 1000 CAPSULE in 1 BOTTLE (71205-910-11)Marketed from Jul 16, 2021 | |
| 71205-910-30 | 71205091030 | 30 CAPSULE in 1 BOTTLE (71205-910-30)Marketed from Jul 16, 2021 | |
| 71205-910-55 | 71205091055 | 500 CAPSULE in 1 BOTTLE (71205-910-55)Marketed from Jul 16, 2021 | |
| 71205-910-60 | 71205091060 | 60 CAPSULE in 1 BOTTLE (71205-910-60)Marketed from Jul 16, 2021 | |
| 71205-910-90 | 71205091090 | 90 CAPSULE in 1 BOTTLE (71205-910-90)Marketed from Jul 16, 2021 |
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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211364
- Marketing start
- Listing expires
- Identifiers
- Product ID 71205-910_be10b430-6ed9-4241-b6d9-818846e80839SPL ID be10b430-6ed9-4241-b6d9-818846e80839SPL set ID ff9ed80e-d692-494f-9741-a9af30fa5000RxCUI 857297, 857301, 857305UNII 2LXW0L6GWJUPC 0371205911607
- 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
N471205091000followed by a unit qualifier and the quantityPackage 71205-0910-00. 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 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. 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 Cl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211364
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 75 mg/1 | CapsuleOral | Leading Pharma, LLC | 69315-165 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | Leading Pharma, LLC | 69315-166 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Leading Pharma, LLC | 69315-167 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | Proficient Rx LP | 71205-911 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-912 |