Prescription drug · ANDA

carbidopa, levodopa and entacapone NDC 46708-800

Carbidopa 50 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)46708-800Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0800Add 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
46708-800-3146708080031100 TABLET, FILM COATED in 1 BOTTLE (46708-800-31)Marketed from Feb 12, 2026
46708-800-91467080800911000 TABLET, FILM COATED in 1 BOTTLE (46708-800-91)Marketed from Feb 12, 2026

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, levodopa and entacapone
Generic name (nonproprietary)
carbidopa, levodopa and entacapone
Active ingredients
Carbidopa — 50 mg/1Levodopa — 200 mg/1Entacapone — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218535
Marketing start
Listing expires
Other FDA classes
Aromatic (Chemical structure)Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers
Product ID 46708-800_9ff83838-b7d0-4eec-98f2-fcc85789a189SPL ID 9ff83838-b7d0-4eec-98f2-fcc85789a189SPL set ID 9ff83838-b7d0-4eec-98f2-fcc85789a189RxCUI 403850, 403851, 403852, 730988, 810083, 810090UNII 46627O600J, MNX7R8C5VO, 4975G9NM6TUPC 0346708797317, 0346708799311, 0346708800314, 0346708798314, 0346708796310, 0346708795313
Pharmacologic class
Aromatic Amino Acid; 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

N446708080031 followed by a unit qualifier and the quantity

Package 46708-0800-31. 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 .

Indications (excerpt from the label)

Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: • To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa (aromatic amino acid), carbidopa (aroma…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218535

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

FDA NDC Directory listings under ANDA 218535
ProductStrengthForm · routeLabelerProduct NDC
carbidopa, levodopa and entacaponeCarbidopa 12.5 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-795
carbidopa, levodopa and entacaponeCarbidopa 31.25 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-798
carbidopa, levodopa and entacaponeCarbidopa 18.75 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-796
carbidopa, levodopa and entacaponeCarbidopa 25 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-797
carbidopa, levodopa and entacaponeCarbidopa 37.5 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-799
carbidopa, levodopa and entacaponeCarbidopa 50 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-800
carbidopa, levodopa and entacaponeCarbidopa 31.25 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-798
carbidopa, levodopa and entacaponeCarbidopa 12.5 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-795
carbidopa, levodopa and entacaponeCarbidopa 18.75 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-796
carbidopa, levodopa and entacaponeCarbidopa 25 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-797
carbidopa, levodopa and entacaponeCarbidopa 37.5 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-799

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carbidopa, levodopa and entacapone NDC 46708-800 | Med-Code