NDC codes

FDA NDC Directory
Product NDC (as listed)16571-694Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16571-0694Add 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
16571-694-011657106940116571069401100 TABLET, FILM COATED in 1 BOTTLE (16571-694-01)Marketed from Aug 5, 2021

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
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213212
Marketing start
Listing expires
Other FDA classes
Aromatic (Chemical structure)Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers
Product ID 16571-694_4d1e7e53-059c-4a41-86b0-66d20ce660d0SPL ID 4d1e7e53-059c-4a41-86b0-66d20ce660d0SPL set ID 2f8e82d7-6baf-456a-b8c3-4fda6e317902RxCUI 403850, 403851, 403852, 730988, 810083, 810090UNII MNX7R8C5VO, 4975G9NM6T, 46627O600JUPC 0316571690015, 0316571694013, 0316571692019, 0316571691012, 0316571693016
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

N416571069401 followed by a unit qualifier and the quantity

Package 16571-0694-01. 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 .

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 (aromatic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-694

What is NDC 16571-694?
16571-694 is the product NDC for Carbidopa, Levodopa And Entacapone, Carbidopa 50 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Carbidopa, Levodopa And Entacapone.
What is the active ingredient?
Carbidopa, Levodopa, Entacapone.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 16571. 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, Levodopa And Entacapone?
29 other product NDCs are listed under this name. See all Carbidopa, Levodopa And 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 Carbidopa, Levodopa And Entacapone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
carbidopa, levodopa and entacaponeCarbidopa 12.5 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-79546708-0795-3146708-0795-91
carbidopa, levodopa and entacaponeCarbidopa 18.75 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-79646708-0796-3146708-0796-91
carbidopa, levodopa and entacaponeCarbidopa 25 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-79746708-0797-3146708-0797-91
carbidopa, levodopa and entacaponeCarbidopa 31.25 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-79846708-0798-3146708-0798-91
carbidopa, levodopa and entacaponeCarbidopa 37.5 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-79946708-0799-3146708-0799-91
carbidopa, levodopa and entacaponeCarbidopa 50 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Limited46708-80046708-0800-3146708-0800-91
carbidopa, levodopa and entacaponeCarbidopa 12.5 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-79562332-0795-3162332-0795-91
carbidopa, levodopa and entacaponeCarbidopa 18.75 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-79662332-0796-3162332-0796-91
carbidopa, levodopa and entacaponeCarbidopa 25 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-79762332-0797-3162332-0797-91
carbidopa, levodopa and entacaponeCarbidopa 31.25 mg/1 + 2 more ingredientsTablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-79862332-0798-3162332-0798-91

All 30 Carbidopa, Levodopa And Entacapone NDCs

Other NDCs under ANDA 213212

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

FDA NDC Directory listings under ANDA 213212
ProductStrengthForm · routeLabelerProduct NDC
Carbidopa, Levodopa And EntacaponeCarbidopa 12.5 mg/1 + 2 more ingredientsTablet, Film coatedOralRising Pharma Holdings, Inc.16571-689
Carbidopa, Levodopa And EntacaponeCarbidopa 18.75 mg/1 + 2 more ingredientsTablet, Film coatedOralRising Pharma Holdings, Inc.16571-690
Carbidopa, Levodopa And EntacaponeCarbidopa 25 mg/1 + 2 more ingredientsTablet, Film coatedOralRising Pharma Holdings, Inc.16571-691
Carbidopa, Levodopa And EntacaponeCarbidopa 31.25 mg/1 + 2 more ingredientsTablet, Film coatedOralRising Pharma Holdings, Inc.16571-692
Carbidopa, Levodopa And EntacaponeCarbidopa 37.5 mg/1 + 2 more ingredientsTablet, Film coatedOralRising Pharma Holdings, Inc.16571-693

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