Prescription drug · NDA AUTHORIZED GENERIC

Rivastigmine NDC 0781-7309

Rivastigmine 9.5 mg/24h · Patch, Extended release · Transdermal · Sandoz Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)0781-7309Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-7309Add 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
0781-7309-31007817309310078173093130 PATCH in 1 CARTON (0781-7309-31) / 24 h in 1 PATCH (0781-7309-58)Marketed from Sep 2, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary)
rivastigmine
Active ingredients
Rivastigmine — 9.5 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 022083
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 0781-7309_3a8271f5-aade-457e-8016-ef0f73c38f78SPL ID 3a8271f5-aade-457e-8016-ef0f73c38f78SPL set ID 92a58ebb-748d-49f4-bf11-ecbcf5424152RxCUI 725021, 725023, 1308569UNII PKI06M3IW0
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

N400781730931 followed by a unit qualifier and the quantity

Package 00781-7309-31. 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)

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 0781-7309

What is NDC 0781-7309?
0781-7309 is the product NDC for Rivastigmine, Rivastigmine 9.5 mg/24h patch, extended release, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rivastigmine.
What is the active ingredient?
Rivastigmine.
Who is the labeler?
Sandoz Inc, NDC labeler code 0781. 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?
16 other product NDCs are listed under this name. See all Rivastigmine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalNorthstar Rx LLC.16714-11616714-0116-02
RivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalNorthstar Rx LLC.16714-11716714-0117-02
RivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalZydus Pharmaceuticals USA Inc.70710-119670710-1196-07
RivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalZydus Pharmaceuticals USA Inc.70710-119770710-1197-07
RivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalZydus Pharmaceuticals USA Inc.70710-119870710-1198-07
RivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalZydus Lifesciences Limited70771-194970771-1949-07
RivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalZydus Lifesciences Limited70771-195070771-1950-07
RivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalZydus Lifesciences Limited70771-195170771-1951-07
RivastigmineRivastigmine 4.6 mg/24hPatchTransdermalMylan Pharmaceuticals Inc.0378-907000378-9070-93
RivastigmineRivastigmine 9.5 mg/24hPatchTransdermalMylan Pharmaceuticals Inc.0378-907100378-9071-93

All 17 Rivastigmine NDCs

Other NDCs under NDA 022083

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

FDA NDC Directory listings under NDA 022083
ProductStrengthForm · routeLabelerProduct NDC
ExelonrivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalNovartis Pharmaceuticals Corporation0078-0501
ExelonrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalNovartis Pharmaceuticals Corporation0078-0502
ExelonrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalNovartis Pharmaceuticals Corporation0078-0503
ExelonrivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalSandoz Inc66758-142
ExelonrivastigmineRivastigmine 9.5 mg/24hPatch, Extended releaseTransdermalSandoz Inc66758-143
ExelonrivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalSandoz Inc66758-144
RivastigmineRivastigmine 4.6 mg/24hPatch, Extended releaseTransdermalSandoz Inc0781-7304
RivastigmineRivastigmine 13.3 mg/24hPatch, Extended releaseTransdermalSandoz Inc0781-7313

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