Prescription drug · ANDA
Entacapone NDC 27241-049
Entacapone 200 mg/1 · Tablet · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-049-10 | 27241004910 | 100 TABLET in 1 BOTTLE (27241-049-10)Marketed from Aug 31, 2017 |
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
- Route
- Oral
- Labeler
- Ajanta Pharma USA Inc.NDC labeler code 27241
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205792
- Marketing start
- Listing expires
- Other FDA classes
- Catechol O-Methyltransferase Inhibitors (Mechanism)
- Identifiers
- Product ID 27241-049_bde2e229-3bc5-4d26-9bd8-0f679955ff33SPL ID bde2e229-3bc5-4d26-9bd8-0f679955ff33SPL set ID e9e94e9f-cd7a-45f5-9aeb-9c28ed804d8cRxCUI 317094UNII 4975G9NM6TUPC 0327241049101
- 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
N427241004910followed by a unit qualifier and the quantityPackage 27241-0049-10. 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 AND USAGE 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 tablet’s 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.
About NDC 27241-049
- What is NDC 27241-049?
- 27241-049 is the product NDC for Entacapone, Entacapone 200 mg/1 tablet, listed with the FDA by Ajanta Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Entacapone.
- What is the active ingredient?
- Entacapone.
- Who is the labeler?
- Ajanta Pharma USA Inc., NDC labeler code 27241. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Entacapone?
- 13 other product NDCs are listed under this name. See all Entacapone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Entacapone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-722 | 64980-0722-01 |
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-478 | 62332-0478-3162332-0478-91 |
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-478 | 46708-0478-3146708-0478-91 |
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | Lannett Company, Inc. | 0527-1830 | 00527-1830-37 |
| Entacapone | Entacapone 200 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8298 | 00615-8298-39 |
| Entacapone | Entacapone 200 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-260 | 33342-0260-1133342-0260-15 |
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-295 | 50268-0295-15 |
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-188 | 60687-0188-21 |
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-654 | 65862-0654-0165862-0654-99 |
| Entacapone | Entacapone 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6822 | 00904-6822-07 |