What is NDC 16571-779?

16571-779 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Donepezil Hydrochloride?

60 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Donepezil Hydrochloride NDC 16571-779

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-779Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0779Add 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
16571-779-03	1657107790316571077903	30 TABLET, FILM COATED in 1 BOTTLE (16571-779-03)Marketed from May 31, 2011
16571-779-09	1657107790916571077909	90 TABLET, FILM COATED in 1 BOTTLE (16571-779-09)Marketed from May 31, 2011
16571-779-10	1657107791016571077910	1000 TABLET, FILM COATED in 1 BOTTLE (16571-779-10)Marketed from May 31, 2011
16571-779-50	1657107795016571077950	500 TABLET, FILM COATED in 1 BOTTLE (16571-779-50)Marketed from May 31, 2011

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): Donepezil Hydrochloride
Generic name (nonproprietary): donepezil hydrochloride
Active ingredients: Donepezil hydrochloride — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090056
Marketing start: May 31, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 16571-779_b963d4b7-66f3-47d7-8671-7412d49e6cb3SPL ID b963d4b7-66f3-47d7-8671-7412d49e6cb3SPL set ID 86b0c5a0-ff3c-4840-a4ac-82af922d58bfRxCUI 997223, 997229UNII 3O2T2PJ89DUPC 0316571778034, 0316571779031
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416571077903 followed by a unit qualifier and the quantity

Package 16571-0779-03. 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

Current FDA label (SPL), effective Jan 8, 2024.

Indications (excerpt from the label)

Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s Disease (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-779

What is NDC 16571-779?: 16571-779 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Donepezil Hydrochloride.
What is the active ingredient?: Donepezil hydrochloride.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Donepezil Hydrochloride?: 60 other product NDCs are listed under this name. See all Donepezil Hydrochloride 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 Donepezil Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Donepezil hydrochloride	Donepezil hydrochloride 23 mg/1	Tablet, Film coatedOral	Dr. Reddys Laboratories Limited	55111-302	55111-0302-3055111-0302-90
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4392	70518-4392-00
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1476	67046-1476-03
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8711	68788-8711-0368788-8711-0668788-8711-09
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8208	68788-8208-0368788-8208-0668788-8208-09
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	DirectRx	72189-265	72189-0265-90
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-031	72189-0031-30
donepezil hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1666	70518-1666-0070518-1666-01
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-019	71209-0019-0171209-0019-0471209-0019-11
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-020	71209-0020-0171209-0020-0471209-0020-11

All 61 Donepezil Hydrochloride NDCs

Other NDCs under ANDA 090056

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

FDA NDC Directory listings under ANDA 090056
Product	Strength	Form · route	Labeler	Product NDC
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-778
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7365
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-9326
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-326
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1476
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8208
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4392
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2093
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2346