What is NDC 0615-8516?

0615-8516 is the product NDC for Carbidopa and Levodopa, Carbidopa 25 mg/1; Levodopa 250 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Carbidopa and Levodopa?

97 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carbidopa and Levodopa NDC 0615-8516

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8516Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8516Add 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
0615-8516-39	0061585163900615851639	30 TABLET in 1 BLISTER PACK (0615-8516-39)Marketed from Nov 27, 2024

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): Carbidopa and Levodopa
Generic name (nonproprietary): carbidopa and levodopa
Active ingredients: Carbidopa — 25 mg/1Levodopa — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073607
Marketing start: May 1, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Aromatic (Chemical structure)
Identifiers: Product ID 0615-8516_4bccc4b9-7399-4dd4-9146-c5b2714f299fSPL ID 4bccc4b9-7399-4dd4-9146-c5b2714f299fSPL set ID 45909de3-0852-4e61-8a9e-23f8fcc2463aRxCUI 197443, 197444, 197445UNII MNX7R8C5VO, 46627O600J
Pharmacologic class: Aromatic Amino Acid

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

N400615851639 followed by a unit qualifier and the quantity

Package 00615-8516-39. 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 Dec 6, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8516

What is NDC 0615-8516?: 0615-8516 is the product NDC for Carbidopa and Levodopa, Carbidopa 25 mg/1; Levodopa 250 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Carbidopa and Levodopa.
What is the active ingredient?: Carbidopa, Levodopa.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carbidopa and Levodopa?: 97 other product NDCs are listed under this name. See all Carbidopa and Levodopa 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 Carbidopa and Levodopa NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Carbidopa and Levodopa	Carbidopa 25 mg/1; Levodopa 250 mg/1	TabletOral	Coupler LLC	67046-1689	67046-1689-03
Carbidopa and Levodopa	Carbidopa 25 mg/1; Levodopa 100 mg/1	TabletOral	AvPAK	50268-202	50268-0202-15
Carbidopa and Levodopa	Carbidopa 48.75 mg/1; Levodopa 195 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4621	70518-4621-00
Carbidopa and Levodopa	Carbidopa 23.75 mg/1; Levodopa 95 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4618	70518-4618-00
Carbidopa and Levodopa	Carbidopa 25 mg/1; Levodopa 250 mg/1	TabletOral	REMEDYREPACK INC.	70518-4620	70518-4620-00
Carbidopa and Levodopa	Carbidopa 36.25 mg/1; Levodopa 145 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4630	70518-4630-00
Carbidopa and Levodopa	Carbidopa 61.25 mg/1; Levodopa 245 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4610	70518-4610-00
Carbidopa And Levodopa	Carbidopa 25 mg/1; Levodopa 250 mg/1	TabletOral	Coupler LLC	67046-1668	67046-1668-03
Carbidopa and Levodopa	Carbidopa hydrate 25 mg/1; Levodopa 100 mg/1	Tablet, Extended releaseOral	Safecor Health, LLC	48433-015	48433-0015-20
Carbidopa and Levodopa	Carbidopa hydrate 50 mg/1; Levodopa 200 mg/1	Tablet, Extended releaseOral	Safecor Health, LLC	48433-016	48433-0016-20

All 98 Carbidopa and Levodopa NDCs

Other NDCs under ANDA 073607

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

FDA NDC Directory listings under ANDA 073607
Product	Strength	Form · route	Labeler	Product NDC
Carbidopa and Levodopa	Carbidopa hydrate 25 mg/1; Levodopa 250 mg/1	TabletOral	Major Pharmaceuticals	0904-7549
Carbidopa and Levodopa	Carbidopa hydrate 25 mg/1; Levodopa 250 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0192
Carbidopa and Levodopa	Carbidopa 25 mg/1; Levodopa 250 mg/1	TabletOral	Dr. Reddy's Laboratories Inc	75907-021