What is NDC 41520-264?

41520-264 is the product NDC for careone naproxen sodium pm, Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by American Sales Company. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

careone naproxen sodium pm (Diphenhydramine hydrochloride, naproxen sodium).

What is the active ingredient?

Diphenhydramine hydrochloride, Naproxen sodium.

American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for careone naproxen sodium pm?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

careone naproxen sodium pm NDC 41520-264

NDC codes

FDA NDC Directory

Product NDC (as listed)41520-264Labeler and product segments. Claims need a package NDC.

Product NDC at billing width41520-0264Add 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
41520-264-27	4152002642741520026427	1 BOTTLE in 1 CARTON (41520-264-27) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 25, 2020
41520-264-60	4152002646041520026460	1 BOTTLE in 1 CARTON (41520-264-60) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 25, 2020

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): careone naproxen sodium pm
Generic name (nonproprietary): diphenhydramine hydrochloride, naproxen sodium
Active ingredients: Diphenhydramine hydrochloride — 25 mg/1Naproxen sodium — 220 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: American Sales CompanyNDC labeler code 41520
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208499
Marketing start: Feb 25, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 41520-264_65baf60d-f7f4-4482-a7a4-3aab220925e2SPL ID 65baf60d-f7f4-4482-a7a4-3aab220925e2SPL set ID 16547905-59c0-4936-82e1-2d9f5935d8ddRxCUI 1550957UNII TC2D6JAD40, 9TN87S3A3C
Pharmacologic class: Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug

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

N441520026427 followed by a unit qualifier and the quantity

Package 41520-0264-27. 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 Dec 11, 2023.

Indications (excerpt from the label)

Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 41520-264

What is NDC 41520-264?: 41520-264 is the product NDC for careone naproxen sodium pm, Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by American Sales Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: careone naproxen sodium pm (Diphenhydramine hydrochloride, naproxen sodium).
What is the active ingredient?: Diphenhydramine hydrochloride, Naproxen sodium.
Who is the labeler?: American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for careone naproxen sodium pm?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 208499

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208499
Product	Strength	Form · route	Labeler	Product NDC
All Night Pain Relief PMdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	Walgreen Company	0363-2264
basic care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	Amazon.com Services LLC	72288-310
dg health naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	Dolgencorp Inc	55910-858
equaline naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	United Natural Foods, Inc. dba UNFI	41163-593
good sense naproxen sodiumdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	L. Perrigo Company	0113-8264
Naproxen Sodium PMdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	Safeway	21130-639
naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	TabletOral	Kroger Company	30142-753
naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	H E B	37808-264
naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	Meijer Distribution Inc	41250-526
topcare all night pain relief pmdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	Topco Associates LLC	36800-264
up and up naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium	Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1	Tablet, Film coatedOral	Target Corporation	11673-687