Prescription drug · NDA AUTHORIZED GENERIC
Entacapone NDC 47335-007
Entacapone 200 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-007-88 | 47335000788 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88)Marketed from Apr 1, 2013 |
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)
- Entacapone
- Generic name (nonproprietary)
- entacapone
- Active ingredients
- Entacapone — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020796
- Marketing start
- Listing expires
- Other FDA classes
- Catechol O-Methyltransferase Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-007_5330dfe5-b7e1-4813-bf9f-b3e932e61796SPL ID 5330dfe5-b7e1-4813-bf9f-b3e932e61796SPL set ID 205522fb-bb0e-414e-a413-a08bef727653RxCUI 317094UNII 4975G9NM6T
- Pharmacologic class
- Catechol-O-Methyltransferase 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
N447335000788followed by a unit qualifier and the quantityPackage 47335-0007-88. 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)
INDICATIONS Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone Tablets’ effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020796
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 |
|---|---|---|---|---|
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | Sandoz Inc | 0781-5578 |
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-247 |