NDC codes

FDA NDC Directory
Product NDC (as listed)65162-825Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0825Add 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
65162-825-34651620825346516208253430 PATCH in 1 CARTON (65162-825-34) / 24 h in 1 PATCHMarketed from Jun 30, 2015

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
Generic name (nonproprietary)
rivastigmine
Active ingredients
Rivastigmine — 4.6 mg/24h
Dosage form
Patch
Route
Transdermal
Labeler
Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207308
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 65162-825_cf03b1e8-cd2f-44ee-afab-2de64b435b45SPL ID cf03b1e8-cd2f-44ee-afab-2de64b435b45SPL set ID 8b671fc9-8cb0-4406-a9ee-7c95086d6200RxCUI 725021, 725023, 1308569UNII PKI06M3IW0UPC 0365162825343, 0365162826340, 0365162749342
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

N465162082534 followed by a unit qualifier and the quantity

Package 65162-0825-34. 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 65162-825

What is NDC 65162-825?
65162-825 is the product NDC for Rivastigmine, Rivastigmine 4.6 mg/24h patch, listed with the FDA by Amneal Pharmaceuticals LLC. 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?
Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 ANDA 207308

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

FDA NDC Directory listings under ANDA 207308
ProductStrengthForm · routeLabelerProduct NDC
RivastigmineRivastigmine 13.3 mg/24hPatchTransdermalAmneal Pharmaceuticals LLC65162-749
RivastigmineRivastigmine 9.5 mg/24hPatchTransdermalAmneal Pharmaceuticals LLC65162-826

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in