NDC codes

FDA NDC Directory
Product NDC (as listed)16714-770Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0770Add 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
16714-770-011671407700130 TABLET in 1 BOTTLE (16714-770-01)Marketed from Apr 17, 2018

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)
Rasagiline
Generic name (nonproprietary)
rasagiline
Active ingredients
Rasagiline mesylate — .5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201889
Marketing start
Listing expires
Other FDA classes
Monoamine Oxidase Inhibitors (Mechanism)
Identifiers
Product ID 16714-770_dfffedf4-c1f0-4bbd-9978-80dcec656d72SPL ID dfffedf4-c1f0-4bbd-9978-80dcec656d72SPL set ID 8bf8e76c-27cb-42a4-aa9c-bdade68c463bRxCUI 608328, 636664UNII LH8C2JI290UPC 0316714771014, 0316714770017
Pharmacologic class
Monoamine Oxidase 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

N416714077001 followed by a unit qualifier and the quantity

Package 16714-0770-01. 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)

Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD). Rasagiline tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201889

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

FDA NDC Directory listings under ANDA 201889
ProductStrengthForm · routeLabelerProduct NDC
RasagilineRasagiline mesylate 1 mg/1TabletOralNorthStar RxLLC16714-771
RasagilineRasagiline mesylate 1 mg/1TabletOralREMEDYREPACK INC.70518-4735
RasagilineRasagiline mesylate .5 mg/1TabletOralAscend Laboratories, LLC67877-259
RasagilineRasagiline mesylate 1 mg/1TabletOralAscend Laboratories, LLC67877-260
RasagilineRasagiline mesylate .5 mg/1TabletOralREMEDYREPACK INC.70518-4683

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