Prescription drug · NDA

Neupro (Rotigotine) NDC 50474-802

Rotigotine 2 mg/24h · Patch, Extended release · Transdermal · UCB, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)50474-802Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50474-0802Add 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
50474-802-035047408020330 POUCH in 1 CARTON (50474-802-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCHMarketed from Apr 2, 2012
50474-802-17504740802177 POUCH in 1 CARTON (50474-802-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCHMarketed from Apr 2, 2012

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)
Neupro
Generic name (nonproprietary)
rotigotine
Active ingredients
Rotigotine — 2 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
UCB, Inc.NDC labeler code 50474
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021829
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 50474-802_5b24ae50-a285-526a-e063-6294a90a9998SPL ID 5b24ae50-a285-526a-e063-6294a90a9998
Pharmacologic class
Nonergot Dopamine Agonist

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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450474080203 followed by a unit qualifier and the quantity

Package 50474-0802-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 50474-802

What is NDC 50474-802?
50474-802 is the product NDC for Neupro (rotigotine), Rotigotine 2 mg/24h patch, extended release, listed with the FDA by UCB, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Neupro (Rotigotine).
What is the active ingredient?
Rotigotine.
Who is the labeler?
UCB, Inc., NDC labeler code 50474. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Neupro?
6 other product NDCs are listed under this name. See all Neupro 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 Neupro NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NeuprorotigotineRotigotine 1 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-80150474-0801-0350474-0801-17
NeuprorotigotineRotigotine 3 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-80350474-0803-0350474-0803-17
NeuprorotigotineRotigotine 4 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-80450474-0804-0350474-0804-17
NeuprorotigotineRotigotine 6 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-80550474-0805-0350474-0805-17
NeuprorotigotineRotigotine 8 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-80650474-0806-0350474-0806-17
Neuprorotigotine—KitUCB, Inc.50474-80850474-0808-11

Other NDCs under NDA 021829

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

FDA NDC Directory listings under NDA 021829
ProductStrengthForm · routeLabelerProduct NDC
NeuprorotigotineRotigotine 1 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-801
NeuprorotigotineRotigotine 3 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-803
NeuprorotigotineRotigotine 4 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-804
NeuprorotigotineRotigotine 6 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-805
NeuprorotigotineRotigotine 8 mg/24hPatch, Extended releaseTransdermalUCB, Inc.50474-806
Neuprorotigotine—KitUCB, Inc.50474-808

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