Prescription drug · ANDA
Clomipramine Hydrochloride NDC 0904-7038
Clomipramine hydrochloride 25 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7038-07 | 0090470380700904703807 | 30 BLISTER PACK in 1 CARTON (0904-7038-07) / 1 CAPSULE in 1 BLISTER PACKMarketed from Dec 31, 1996 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074694
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7038_b7641ab7-974c-4814-97ba-44cf2ca7e10fSPL ID b7641ab7-974c-4814-97ba-44cf2ca7e10fSPL set ID eff91018-5a5e-4426-96ae-71ecd82273b7RxCUI 857297, 857301UNII 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
N400904703807followed by a unit qualifier and the quantityPackage 00904-7038-07. 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.
About NDC 0904-7038
- What is NDC 0904-7038?
- 0904-7038 is the product NDC for Clomipramine Hydrochloride, Clomipramine hydrochloride 25 mg/1 capsule, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clomipramine Hydrochloride.
- What is the active ingredient?
- Clomipramine hydrochloride.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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 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 50 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7039 |
| 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 50 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 51672-4012 |
| 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 |