NDC codes

FDA NDC Directory
Product NDC (as listed)42799-954Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42799-0954Add 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
42799-954-01427990954014279909540130 TABLET, FILM COATED in 1 BOTTLE (42799-954-01)Marketed from Dec 5, 2023
42799-954-02427990954024279909540290 TABLET, FILM COATED in 1 BOTTLE (42799-954-02)Marketed from Dec 5, 2023

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 — 23 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203713
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 42799-954_19147d81-49ac-463e-8643-26dace803ea5SPL ID 19147d81-49ac-463e-8643-26dace803ea5SPL set ID 11404dc3-1bde-4d4e-8386-006b67ee19ddRxCUI 1100184UNII 3O2T2PJ89DUPC 0342799954028, 0342799954011
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

N442799095401 followed by a unit qualifier and the quantity

Package 42799-0954-01. 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 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 hydrochloride tablets are 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 42799-954

What is NDC 42799-954?
42799-954 is the product NDC for Donepezil hydrochloride, Donepezil hydrochloride 23 mg/1 tablet, film coated, listed with the FDA by Edenbridge Pharmaceuticals LLC.. 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?
Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. 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 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-166670518-1666-0070518-1666-01
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

All 61 Donepezil hydrochloride NDCs

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