What is NDC 55111-302?

55111-302 is the product NDC for Donepezil hydrochloride, Donepezil hydrochloride 23 mg/1 tablet, film coated, listed with the FDA by Dr. Reddys Laboratories Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddys Laboratories Limited, NDC labeler code 55111. 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 55111-302

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-302Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0302Add 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	Copy
55111-302-30	5511103023055111030230	30 TABLET, FILM COATED in 1 BOTTLE (55111-302-30)Marketed from Aug 20, 2025
55111-302-90	5511103029055111030290	90 TABLET, FILM COATED in 1 BOTTLE (55111-302-90)Marketed from Aug 20, 2025

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: Dr. Reddys Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202723
Marketing start: Aug 20, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 55111-302_0df6bfb2-4604-2035-9677-06c125e77bb9SPL ID 0df6bfb2-4604-2035-9677-06c125e77bb9SPL set ID 7c0d3bcb-157d-0414-64ee-055bc614d190RxCUI 1100184UNII 3O2T2PJ89DUPC 0355111302308
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

N455111030230 followed by a unit qualifier and the quantity

Package 55111-0302-30. 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 Apr 11, 2025.

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 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 55111-302

What is NDC 55111-302?: 55111-302 is the product NDC for Donepezil hydrochloride, Donepezil hydrochloride 23 mg/1 tablet, film coated, listed with the FDA by Dr. Reddys Laboratories Limited. 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?: Dr. Reddys Laboratories Limited, NDC labeler code 55111. 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 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
donepezil hydrochloride	Donepezil hydrochloride 5 mg/1	Tablet, Orally disintegratingOral	Unichem Pharmaceuticals (USA), Inc.	29300-250	29300-0250-87

All 61 Donepezil hydrochloride NDCs