What is NDC 0378-9071?

0378-9071 is the product NDC for Rivastigmine, Rivastigmine 9.5 mg/24h patch, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rivastigmine NDC 0378-9071 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-9071Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-9071Add 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 NDC	11-digit (billing)	Package	Copy
0378-9071-93	0037890719300378907193	30 POUCH in 1 CARTON (0378-9071-93) / 1 PATCH in 1 POUCH (0378-9071-16) / 24 h in 1 PATCHMarketed from Jun 20, 2018

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
Route: Transdermal
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205622
Marketing start: Jun 20, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 0378-9071_c1d8c8a9-87e9-4ca1-ba70-4a7467205fd4SPL ID c1d8c8a9-87e9-4ca1-ba70-4a7467205fd4SPL set ID 4ab335d1-19ee-4cd9-9776-8086645d19e4RxCUI 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

N400378907193 followed by a unit qualifier and the quantity

Package 00378-9071-93. 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 Sep 21, 2024.

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 0378-9071

What is NDC 0378-9071?: 0378-9071 is the product NDC for Rivastigmine, Rivastigmine 9.5 mg/24h patch, listed with the FDA by Mylan Pharmaceuticals 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rivastigmine	Rivastigmine 9.5 mg/24h	Patch, Extended releaseTransdermal	Northstar Rx LLC.	16714-116	16714-0116-02
Rivastigmine	Rivastigmine 13.3 mg/24h	Patch, Extended releaseTransdermal	Northstar Rx LLC.	16714-117	16714-0117-02
Rivastigmine	Rivastigmine 4.6 mg/24h	Patch, Extended releaseTransdermal	Zydus Pharmaceuticals USA Inc.	70710-1196	70710-1196-07
Rivastigmine	Rivastigmine 9.5 mg/24h	Patch, Extended releaseTransdermal	Zydus Pharmaceuticals USA Inc.	70710-1197	70710-1197-07
Rivastigmine	Rivastigmine 13.3 mg/24h	Patch, Extended releaseTransdermal	Zydus Pharmaceuticals USA Inc.	70710-1198	70710-1198-07
Rivastigmine	Rivastigmine 4.6 mg/24h	Patch, Extended releaseTransdermal	Zydus Lifesciences Limited	70771-1949	70771-1949-07
Rivastigmine	Rivastigmine 9.5 mg/24h	Patch, Extended releaseTransdermal	Zydus Lifesciences Limited	70771-1950	70771-1950-07
Rivastigmine	Rivastigmine 13.3 mg/24h	Patch, Extended releaseTransdermal	Zydus Lifesciences Limited	70771-1951	70771-1951-07
Rivastigmine	Rivastigmine 4.6 mg/24h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-9070	00378-9070-93
Rivastigmine	Rivastigmine 13.3 mg/24h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-9072	00378-9072-93

All 17 Rivastigmine NDCs

Other NDCs under ANDA 205622

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

FDA NDC Directory listings under ANDA 205622
Product	Strength	Form · route	Labeler	Product NDC
Rivastigmine	Rivastigmine 4.6 mg/24h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-9070
Rivastigmine	Rivastigmine 13.3 mg/24h	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-9072