NDC codes

FDA NDC Directory
Product NDC (as listed)51079-978Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51079-0978Add 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 NDC11-digit (billing)PackageCopy
51079-978-205107909782051079097820100 BLISTER PACK in 1 CARTON (51079-978-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-978-01)Marketed from Feb 1, 2002

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)
Carbidopa and Levodopa
Generic name (nonproprietary)
carbidopa and levodopa
Active ingredients
Carbidopa — 25 mg/1Levodopa — 100 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Mylan Institutional Inc.NDC labeler code 51079
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075091
Marketing start
Listing expires
Other FDA classes
Aromatic (Chemical structure)
Identifiers
Product ID 51079-978_3a39bb13-44d1-2652-e063-6294a90ad211SPL ID 3a39bb13-44d1-2652-e063-6294a90ad211SPL set ID 16f9e4d1-6953-4d4f-b4cf-ad95a856ac25RxCUI 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

N451079097820 followed by a unit qualifier and the quantity

Package 51079-0978-20. 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 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 51079-978

What is NDC 51079-978?
51079-978 is the product NDC for Carbidopa and Levodopa, Carbidopa 25 mg/1; Levodopa 100 mg/1 tablet, extended release, listed with the FDA by Mylan Institutional 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 Institutional Inc., NDC labeler code 51079. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Carbidopa and LevodopaCarbidopa 25 mg/1; Levodopa 250 mg/1TabletOralCoupler LLC67046-168967046-1689-03
Carbidopa and LevodopaCarbidopa 25 mg/1; Levodopa 100 mg/1TabletOralAvPAK50268-20250268-0202-15
Carbidopa and LevodopaCarbidopa 48.75 mg/1; Levodopa 195 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-462170518-4621-00
Carbidopa and LevodopaCarbidopa 23.75 mg/1; Levodopa 95 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-461870518-4618-00
Carbidopa and LevodopaCarbidopa 25 mg/1; Levodopa 250 mg/1TabletOralREMEDYREPACK INC.70518-462070518-4620-00
Carbidopa and LevodopaCarbidopa 36.25 mg/1; Levodopa 145 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-463070518-4630-00
Carbidopa and LevodopaCarbidopa 61.25 mg/1; Levodopa 245 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-461070518-4610-00
Carbidopa And LevodopaCarbidopa 25 mg/1; Levodopa 250 mg/1TabletOralCoupler LLC67046-166867046-1668-03
Carbidopa and LevodopaCarbidopa hydrate 25 mg/1; Levodopa 100 mg/1Tablet, Extended releaseOralSafecor Health, LLC48433-01548433-0015-20
Carbidopa and LevodopaCarbidopa hydrate 50 mg/1; Levodopa 200 mg/1Tablet, Extended releaseOralSafecor Health, LLC48433-01648433-0016-20

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
ProductStrengthForm · routeLabelerProduct NDC
Carbidopa and LevodopaCarbidopa 25 mg/1; Levodopa 100 mg/1Tablet, Extended releaseOralMylan Pharmaceuticals Inc.0378-0088
Carbidopa and LevodopaCarbidopa 50 mg/1; Levodopa 200 mg/1Tablet, Extended releaseOralMylan Pharmaceuticals Inc.0378-0094
Carbidopa and LevodopaCarbidopa hydrate 25 mg/1; Levodopa 100 mg/1Tablet, Extended releaseOralSafecor Health, LLC48433-015
Carbidopa and LevodopaCarbidopa hydrate 50 mg/1; Levodopa 200 mg/1Tablet, Extended releaseOralSafecor Health, LLC48433-016
Carbidopa and LevodopaCarbidopa 50 mg/1; Levodopa 200 mg/1Tablet, Extended releaseOralMylan Institutional Inc.51079-923

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