Prescription drug · ANDA

Rivastigmine Transdermal System (Rivastigmine) NDC 51991-897

Rivastigmine 4.6 mg/24h · Patch, Extended release · Transdermal · Breckenridge Pharmaceutical, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51991-897Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51991-0897Add 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
51991-897-30519910897305199108973030 POUCH in 1 CARTON (51991-897-30) / 1 PATCH in 1 POUCH (51991-897-99) / 24 h in 1 PATCHMarketed from Dec 19, 2019

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)
Rivastigmine Transdermal System
Generic name (nonproprietary)
rivastigmine
Active ingredients
Rivastigmine — 4.6 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209063
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 51991-897_6c0c606b-108e-4837-8533-f485f9e4ee4bSPL ID 6c0c606b-108e-4837-8533-f485f9e4ee4bSPL set ID b201fe68-b5e5-4a6f-8cf1-069543f03e76RxCUI 725021, 725023, 1308569UNII PKI06M3IW0UPC 0351991899303
Pharmacologic class
Cholinesterase 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N451991089730 followed by a unit qualifier and the quantity

Package 51991-0897-30. 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)

Rivastigmine Transdermal System is an acetylcholinesterase inhibitor indicated for treatment of: Mild, moderate, and severe dementia of the Alzheimer's type (AD) ( 1.1 ) Mild-to-moderate dementia associated with Parkinson's disease (PD) ( 1.2 ) 1.1 Alzheimer's Disease Rivastigmine Transdermal System is indicated for the treatment of dementia of the Alzheimer's type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease. 1.2 Parkinson's Disease Dementia Rivastigmine Transdermal System is indicated for the treatment of mild-to-moderate dementia associated with Parkinson's disease (PDD).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51991-897

What is NDC 51991-897?
51991-897 is the product NDC for Rivastigmine Transdermal System (rivastigmine), Rivastigmine 4.6 mg/24h patch, extended release, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rivastigmine Transdermal System (Rivastigmine).
What is the active ingredient?
Rivastigmine.
Who is the labeler?
Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rivastigmine Transdermal System?
10 other product NDCs are listed under this name. See all Rivastigmine Transdermal System 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 Rivastigmine Transdermal System NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Rivastigmine Transdermal SystemrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalBreckenridge Pharmaceutical, Inc.51991-89851991-0898-30
Rivastigmine Transdermal SystemrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalBreckenridge Pharmaceutical, Inc.51991-89951991-0899-30
Rivastigmine Transdermal SystemrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-206463629-2064-01
Rivastigmine Transdermal SystemrivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-206563629-2065-01
Rivastigmine Transdermal SystemrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-206663629-2066-01
Rivastigmine Transdermal SystemrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-880763629-8807-01
Rivastigmine Transdermal SystemrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-884663629-8846-01
Rivastigmine Transdermal SystemrivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack72162-160872162-1608-03
Rivastigmine Transdermal SystemrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack72162-160972162-1609-03
Rivastigmine Transdermal SystemrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack72162-161072162-1610-03

Other NDCs under ANDA 209063

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

FDA NDC Directory listings under ANDA 209063
ProductStrengthForm · routeLabelerProduct NDC
Rivastigmine Transdermal SystemrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalBreckenridge Pharmaceutical, Inc.51991-898
Rivastigmine Transdermal SystemrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalBreckenridge Pharmaceutical, Inc.51991-899
Rivastigmine Transdermal SystemrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-2064
Rivastigmine Transdermal SystemrivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-2065
Rivastigmine Transdermal SystemrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-2066
Rivastigmine Transdermal SystemrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-8807
Rivastigmine Transdermal SystemrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack63629-8846
Rivastigmine Transdermal SystemrivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack72162-1608
Rivastigmine Transdermal SystemrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack72162-1609
Rivastigmine Transdermal SystemrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalBryant Ranch Prepack72162-1610

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