What is NDC 46708-478?

46708-478 is the product NDC for Entacapone, Entacapone 200 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Entacapone NDC 46708-478 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0478Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
46708-478-31	46708047831	100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31)Marketed from Jan 6, 2022
46708-478-91	46708047891	1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91)Marketed from Jan 6, 2022

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
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212601
Marketing start: Jan 6, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 46708-478_49e45c73-b4c8-4f0e-8ad7-5a025ca5d5c8SPL ID 49e45c73-b4c8-4f0e-8ad7-5a025ca5d5c8SPL set ID d21ce241-b05a-413e-b19a-249ae42012a8RxCUI 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

N446708047831 followed by a unit qualifier and the quantity

Package 46708-0478-31. 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 Jan 9, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 46708-478

What is NDC 46708-478?: 46708-478 is the product NDC for Entacapone, Entacapone 200 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Entacapone NDCs
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	Lannett Company, Inc.	0527-1830	00527-1830-37
Entacapone	Entacapone 200 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-049	27241-0049-10
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

All 14 Entacapone NDCs

Other NDCs under ANDA 212601

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212601
Product	Strength	Form · route	Labeler	Product NDC
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-478