Prescription drug · ANDA
Clomipramine Hydrochloride NDC 69315-167
Clomipramine hydrochloride 25 mg/1 · Capsule · Oral · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-167-01 | 69315016701 | 100 CAPSULE in 1 BOTTLE (69315-167-01)Marketed from Mar 10, 2020 | |
| 69315-167-03 | 69315016703 | 30 CAPSULE in 1 BOTTLE (69315-167-03)Marketed from Mar 10, 2020 | |
| 69315-167-09 | 69315016709 | 90 CAPSULE in 1 BOTTLE (69315-167-09)Marketed from Mar 10, 2020 |
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
- Leading Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211364
- Marketing start
- Listing expires
- Identifiers
- Product ID 69315-167_48996a58-a312-4a01-ba38-0261a18bec65SPL ID 48996a58-a312-4a01-ba38-0261a18bec65SPL set ID fa0d4de8-c96e-429d-a65c-928afbf46863RxCUI 857297, 857301, 857305UNII 2LXW0L6GWJUPC 0369315167014, 0369315167038, 0369315165034, 0369315167090
- 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
N469315016701followed by a unit qualifier and the quantityPackage 69315-0167-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 50 mg/1 | CapsuleOral | Proficient Rx LP | 71205-911 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-910 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-912 |