What is NDC 71335-0900?

71335-0900 is the product NDC for donepezil hydrochloride, Donepezil hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-0900

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0900Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0900Add 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
71335-0900-1	7133509000171335090001	30 TABLET, FILM COATED in 1 BOTTLE (71335-0900-1)Marketed from Oct 1, 2019
71335-0900-2	7133509000271335090002	60 TABLET, FILM COATED in 1 BOTTLE (71335-0900-2)Marketed from Jan 28, 2022
71335-0900-3	7133509000371335090003	90 TABLET, FILM COATED in 1 BOTTLE (71335-0900-3)Marketed from Jul 12, 2018

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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200292
Marketing start: Nov 1, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 71335-0900_fde8f515-e602-4b77-a4ad-2e829bdaf193SPL ID fde8f515-e602-4b77-a4ad-2e829bdaf193SPL set ID c26d9bf3-e148-48bb-8f4f-e8c73804b311RxCUI 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

N471335090001 followed by a unit qualifier and the quantity

Package 71335-0900-01. 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 Nov 17, 2023.

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 71335-0900

What is NDC 71335-0900?: 71335-0900 is the product NDC for donepezil hydrochloride, Donepezil hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 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
Product	Strength	Form · route	Labeler	Product NDC
donepezil hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-275
donepezil hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-276
donepezil hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-878
donepezil hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	Solco Healthcare US, LLC	43547-879
donepezil hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3537
donepezil hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1666
Donepezil Hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-031
Donepezil Hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	DirectRx	72189-265
donepezil hydrochloride	Donepezil hydrochloride 10 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	87063-304
donepezil hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	87063-305