Prescription drug · ANDA

donepezil hydrochloride NDC 43547-878

Donepezil hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Solco Healthcare US, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)43547-878Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0878Add 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
43547-878-034354708780330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-878-03)Marketed from Nov 1, 2011
43547-878-094354708780990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-878-09)Marketed from Nov 1, 2011
43547-878-11435470878111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-878-11)Marketed from Nov 1, 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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200292
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 43547-878_cd5f4526-14a5-4571-9ef1-f352172dbc44SPL ID cd5f4526-14a5-4571-9ef1-f352172dbc44SPL set ID 48178cb4-4fee-47c0-88e9-a4f017f1f448RxCUI 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

N443547087803 followed by a unit qualifier and the quantity

Package 43547-0878-03. 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 .

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)

Other NDCs under ANDA 200292

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

FDA NDC Directory listings under ANDA 200292
ProductStrengthForm · routeLabelerProduct NDC
donepezil hydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1666
donepezil hydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralASCLEMED USA INC.87063-304
donepezil hydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralASCLEMED USA INC.87063-305
Donepezil HydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralDirect_Rx72189-031
donepezil hydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0900
donepezil hydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-879
donepezil hydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3537
donepezil hydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-275
donepezil hydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-276
Donepezil HydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralDirectRx72189-265

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donepezil hydrochloride NDC 43547-878 | Med-Code