What is NDC 0378-0094?

0378-0094 is the product NDC for Carbidopa and Levodopa, Carbidopa 50 mg/1; Levodopa 200 mg/1 tablet, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-0094

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0094Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0094Add 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
0378-0094-01	0037800940100378009401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0094-01)Marketed from Oct 6, 1999

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 — 50 mg/1Levodopa — 200 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075091
Marketing start: Oct 6, 1999
Listing expires: Dec 31, 2027
Other FDA classes: Aromatic (Chemical structure)
Identifiers: Product ID 0378-0094_164375a9-db50-4cb3-86ca-a52a3e74cc83SPL ID 164375a9-db50-4cb3-86ca-a52a3e74cc83SPL set ID aa5028d6-fd0a-4cf1-b708-c93bb2a7c76aRxCUI 308988, 308989UNII 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

N400378009401 followed by a unit qualifier and the quantity

Package 00378-0094-01. 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 Apr 24, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-0094

What is NDC 0378-0094?: 0378-0094 is the product NDC for Carbidopa and Levodopa, Carbidopa 50 mg/1; Levodopa 200 mg/1 tablet, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 075091

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

FDA NDC Directory listings under ANDA 075091
Product	Strength	Form · route	Labeler	Product NDC
Carbidopa and Levodopa	Carbidopa 25 mg/1; Levodopa 100 mg/1	Tablet, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-0088
Carbidopa and Levodopa	Carbidopa hydrate 25 mg/1; Levodopa 100 mg/1	Tablet, Extended releaseOral	Safecor Health, LLC	48433-015
Carbidopa and Levodopa	Carbidopa hydrate 50 mg/1; Levodopa 200 mg/1	Tablet, Extended releaseOral	Safecor Health, LLC	48433-016
Carbidopa and Levodopa	Carbidopa 50 mg/1; Levodopa 200 mg/1	Tablet, Extended releaseOral	Mylan Institutional Inc.	51079-923
Carbidopa and Levodopa	Carbidopa 25 mg/1; Levodopa 100 mg/1	Tablet, Extended releaseOral	Mylan Institutional Inc.	51079-978