What is NDC 0615-7951?

0615-7951 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 0615-7951

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-7951Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-7951Add 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
0615-7951-05	0061579510500615795105	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-05)Marketed from Aug 17, 2012
0615-7951-39	0061579513900615795139	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-39)Marketed from Aug 17, 2012

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): Donepezil Hydrochloride
Generic name (nonproprietary): donepezil hydrochloride
Active ingredients: Donepezil hydrochloride — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201146
Marketing start: Aug 17, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 0615-7951_4d853615-465a-436e-b50d-c7bfea279919SPL ID 4d853615-465a-436e-b50d-c7bfea279919SPL set ID ac857917-74db-4591-be9f-d1c822c68c81RxCUI 997223, 997229UNII 3O2T2PJ89D
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

N400615795105 followed by a unit qualifier and the quantity

Package 00615-7951-05. 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 Jul 18, 2024.

Indications (excerpt from the label)

Donepezil hydrochloride is 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 hydrochloride 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 0615-7951

What is NDC 0615-7951?: 0615-7951 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 201146

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

FDA NDC Directory listings under ANDA 201146
Product	Strength	Form · route	Labeler	Product NDC
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8313
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-027
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-028
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6329
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0416
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2022