Prescription drug · NDA
Anafranil (Clomipramine hydrochloride) NDC 0406-9906
Clomipramine hydrochloride 25 mg/1 · Capsule · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-9906-03 | 0040699060300406990603 | 30 CAPSULE in 1 BOTTLE (0406-9906-03)Marketed from Dec 29, 1989 |
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)
- Anafranil
- Generic name (nonproprietary)
- clomipramine hydrochloride
- Active ingredients
- Clomipramine hydrochloride — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 0406
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019906
- Marketing start
- Listing expires
- Identifiers
- Product ID 0406-9906_07af3867-7f3e-4e1c-8100-ad276cb6185fSPL ID 07af3867-7f3e-4e1c-8100-ad276cb6185fSPL set ID 4074b555-7635-41a9-809d-fae3b3610059RxCUI 857297, 857299, 857301, 857303, 857305, 857307UNII 2LXW0L6GWJUPC 0304069908032, 0304069906038, 0304069907035
- 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
N400406990603followed by a unit qualifier and the quantityPackage 00406-9906-03. 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 Anafranil ™ (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 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 effec…
Excerpt only. Read the full label for complete information.
About NDC 0406-9906
- What is NDC 0406-9906?
- 0406-9906 is the product NDC for Anafranil (clomipramine hydrochloride), Clomipramine hydrochloride 25 mg/1 capsule, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Anafranil (Clomipramine hydrochloride).
- What is the active ingredient?
- Clomipramine hydrochloride.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 0406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Anafranil?
- 2 other product NDCs are listed under this name. See all Anafranil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Anafranil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Anafranilclomipramine hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | SpecGx LLC | 0406-9907 | 00406-9907-03 |
| Anafranilclomipramine hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | SpecGx LLC | 0406-9908 | 00406-9908-03 |
Other NDCs under NDA 019906
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 |
|---|---|---|---|---|
| Anafranilclomipramine hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | SpecGx LLC | 0406-9907 |
| Anafranilclomipramine hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | SpecGx LLC | 0406-9908 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 25 mg/1 | CapsuleOral | SpecGx LLC | 0406-8806 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 50 mg/1 | CapsuleOral | SpecGx LLC | 0406-8807 |
| Clomipramine Hydrochloride | Clomipramine hydrochloride 75 mg/1 | CapsuleOral | SpecGx LLC | 0406-8808 |