NDC codes

FDA NDC Directory
Product NDC (as listed)70518-1666Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-1666Add 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
70518-1666-0705181666007051816660090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1666-0)Marketed from Nov 12, 2018
70518-1666-17051816660170518166601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1666-1)Marketed from Mar 29, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
REMEDYREPACK INC.NDC labeler code 70518
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 70518-1666_4e3cd922-0ae5-3fad-e063-6294a90a1a91SPL ID 4e3cd922-0ae5-3fad-e063-6294a90a1a91SPL set ID 41c095b6-acd9-4627-a813-bbca7ecafee5RxCUI 997223UNII 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

N470518166600 followed by a unit qualifier and the quantity

Package 70518-1666-00. 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)

About NDC 70518-1666

What is NDC 70518-1666?
70518-1666 is the product NDC for donepezil hydrochloride, Donepezil hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. 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?
REMEDYREPACK INC., NDC labeler code 70518. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Donepezil hydrochlorideDonepezil hydrochloride 23 mg/1Tablet, Film coatedOralDr. Reddys Laboratories Limited55111-30255111-0302-3055111-0302-90
Donepezil HydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-439270518-4392-00
Donepezil HydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralCoupler LLC67046-147667046-1476-03
Donepezil HydrochlorideDonepezil hydrochloride 5 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-871168788-8711-0368788-8711-0668788-8711-09
Donepezil HydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-820868788-8208-0368788-8208-0668788-8208-09
Donepezil HydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralDirectRx72189-26572189-0265-90
Donepezil HydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralDirect_Rx72189-03172189-0031-30
Donepezil HydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-01971209-0019-0171209-0019-0471209-0019-11
Donepezil HydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-02071209-0020-0171209-0020-0471209-0020-11
donepezil hydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Orally disintegratingOralUnichem Pharmaceuticals (USA), Inc.29300-25029300-0250-87

All 61 donepezil hydrochloride NDCs

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 5 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-275
donepezil hydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-276
donepezil hydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralSolco Healthcare US, LLC43547-878
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 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0900
Donepezil HydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralDirect_Rx72189-031
Donepezil HydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralDirectRx72189-265
donepezil hydrochlorideDonepezil hydrochloride 10 mg/1Tablet, Film coatedOralASCLEMED USA INC.87063-304
donepezil hydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Film coatedOralASCLEMED USA INC.87063-305

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