Prescription drug · ANDA
Clomipramine Hydrochloride (Clomipramine hydrochloride capsules) NDC 68180-493
Clomipramine hydrochloride 50 mg/1 · Capsule · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-493-01 | 6818004930168180049301 | 100 CAPSULE in 1 BOTTLE (68180-493-01)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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209294
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-493_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
N468180049301followed by a unit qualifier and the quantityPackage 68180-0493-01. 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.
About NDC 68180-493
- What is NDC 68180-493?
- 68180-493 is the product NDC for Clomipramine Hydrochloride (clomipramine hydrochloride capsules), Clomipramine hydrochloride 50 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clomipramine Hydrochloride (Clomipramine Hydrochloride Capsules).
- What is the active ingredient?
- Clomipramine hydrochloride.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clomipramine Hydrochloride?
- 45 other product NDCs are listed under this name. See all Clomipramine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clomipramine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-383 | 59651-0383-0159651-0383-3059651-0383-90 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-407 | 46708-0407-3046708-0407-3146708-0407-90 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-408 | 46708-0408-3046708-0408-3146708-0408-90 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-409 | 46708-0409-3046708-0409-3146708-0409-90 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-407 | 62332-0407-3062332-0407-3162332-0407-90 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-408 | 62332-0408-3062332-0408-3162332-0408-90 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-409 | 62332-0409-3062332-0409-3162332-0409-90 |
| Clomipramine hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-210 | 27241-0210-0127241-0210-30 |
| Clomipramine hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-211 | 27241-0211-0127241-0211-30 |
| Clomipramine hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-212 | 27241-0212-0127241-0212-30 |
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 25 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-492 |
| Clomipramine Hydrochlorideclomipramine hydrochloride capsules | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-494 |