Prescription drug · NDA
Cialis (tadalafil) NDC 0002-4462
Tadalafil 5 mg/1 · Tablet, Film coated · Oral · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-4462-30 | 00002446230 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30)Marketed from Nov 26, 2003 |
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)
- Cialis
- Generic name (nonproprietary)
- tadalafil
- Active ingredients
- Tadalafil — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021368
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 0002-4462_2b22fb0c-f97a-4008-a83b-1695396ef11dSPL ID 2b22fb0c-f97a-4008-a83b-1695396ef11dSPL set ID bcd8f8ab-81a2-4891-83db-24a0b0e25895RxCUI 402019, 402096, 402097, 403957, 404711, 484814UNII 742SXX0ICTUPC 0300024463301, 0300024464308, 0300024462304
- Pharmacologic class
- Phosphodiesterase 5 Inhibitor
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
N400002446230followed by a unit qualifier and the quantityPackage 00002-4462-30. 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 .
Indications (excerpt from the label)
CIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction CIALIS ® is indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia CIALIS is indicated for the treatment of ED and the signs…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021368
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.