NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8711Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8711Add 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
68788-8711-3687888711036878887110330 TABLET in 1 BOTTLE (68788-8711-3)Marketed from Jul 8, 2024
68788-8711-6687888711066878887110660 TABLET in 1 BOTTLE (68788-8711-6)Marketed from Jul 8, 2024
68788-8711-9687888711096878887110990 TABLET in 1 BOTTLE (68788-8711-9)Marketed from Jul 8, 2024

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 — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078662
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 68788-8711_c9fdb857-2048-40fe-a3d1-4e89dda6cdf4SPL ID c9fdb857-2048-40fe-a3d1-4e89dda6cdf4SPL set ID ee54a472-6783-41df-b8bb-9c3e4c996907RxCUI 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

N468788871103 followed by a unit qualifier and the quantity

Package 68788-8711-03. 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 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 68788-8711

What is NDC 68788-8711?
68788-8711 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 5 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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/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
donepezil hydrochlorideDonepezil hydrochloride 5 mg/1Tablet, Orally disintegratingOralUnichem Pharmaceuticals (USA), Inc.29300-25029300-0250-87

All 61 Donepezil Hydrochloride NDCs

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