Over-the-counter drug · NDA

Aleve (Naproxen sodium) NDC 0280-6080

Naproxen sodium 220 mg/1 · Capsule, Liquid filled · Oral · Bayer HealthCare LLC.

NDC codes

FDA NDC Directory
Product NDC (as listed)0280-6080Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00280-6080Add 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
0280-6080-0100280608001002806080011 BOTTLE in 1 CARTON (0280-6080-01) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 20, 2007
0280-6080-0200280608002002806080022 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 20, 2007
0280-6080-0400280608004002806080041 BOTTLE, PLASTIC in 1 CARTON (0280-6080-04) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Oct 20, 2022
0280-6080-160028060801600280608016160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-6080-16)Marketed from Feb 20, 2007
0280-6080-2000280608020002806080201 BOTTLE, PLASTIC in 1 CARTON (0280-6080-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Feb 20, 2007
0280-6080-4000280608040002806080401 BOTTLE, PLASTIC in 1 CARTON (0280-6080-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Feb 20, 2007
0280-6080-8000280608080002806080801 BOTTLE, PLASTIC in 1 CARTON (0280-6080-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Feb 20, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Aleve
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 220 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Bayer HealthCare LLC.NDC labeler code 0280
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021920
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0280-6080_4526c253-b571-1d84-e063-6394a90ae3f9SPL ID 4526c253-b571-1d84-e063-6394a90ae3f9SPL set ID 1266393e-b55e-4e34-9710-0b87209f4158RxCUI 1112231, 1112233UNII 9TN87S3A3CUPC 0325866528124

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

N400280608001 followed by a unit qualifier and the quantity

Package 00280-6080-01. 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)

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0280-6080

What is NDC 0280-6080?
0280-6080 is the product NDC for Aleve (naproxen sodium), Naproxen sodium 220 mg/1 capsule, liquid filled, listed with the FDA by Bayer HealthCare LLC.. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aleve (Naproxen Sodium).
What is the active ingredient?
Naproxen sodium.
Who is the labeler?
Bayer HealthCare LLC., NDC labeler code 0280. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aleve?
8 other product NDCs are listed under this name. See all Aleve 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 Aleve NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Alevenaproxen sodiumNaproxen sodium 220 mg/1TabletOralBayer HealthCare LLC.0280-011300280-0113-0100280-0113-0200280-0113-03+3 more
Alevenaproxen sodiumNaproxen sodium 220 mg/1TabletOralLil' Drug Store Products, Inc66715-650266715-6502-02
Alevenaproxen sodiumNaproxen sodium 220 mg/1TabletOralLil' Drug Store Products, Inc66715-640266715-6402-08
Alevenaproxen sodiumNaproxen sodium 220 mg/1TabletOralNavajo Manufacturing Company Inc67751-14467751-0144-0367751-0144-04
Alevenaproxen sodiumNaproxen sodium 220 mg/1TabletOralR J General Corporation70264-01170264-0011-01
Alevenaproxen sodium tabletNaproxen sodium 220 mg/1TabletOralLil' Drug Store Products, Inc66715-510366715-5103-00
Alevenaproxen sodiumNaproxen sodium 220 mg/1TabletOralBayer HealthCare LLC.0280-601000280-6010-0100280-6010-0200280-6010-03+8 more
Alevenaproxen sodiumNaproxen sodium 220 mg/1TabletOralLil' Drug Store Products, Inc66715-970266715-9702-0266715-9702-03

Other NDCs under NDA 021920

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

FDA NDC Directory listings under NDA 021920
ProductStrengthForm · routeLabelerProduct NDC
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralWal-Mart Stores, Inc.49035-382
naproxen sodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-259
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralDISCOUNT DRUG MART, INC.53943-179
naproxen sodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-284
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralSUPERVALU INC41163-079
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralVALU MERCHANDISERS COMPANY63941-681
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralAMERISOURCE BERGEN46122-780
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.63868-830
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralMEIJER DISTRIBUTION INC41250-225
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralTARGET Corporation11673-651
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralPremier Value Alliance LLC68016-056
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralAmazon.com Services LLC72288-312
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralKROGER COMPANY30142-285
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralHEB37808-049
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralTOP CARE (Topco Associates LLC)36800-204
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralRite Aid Corporation11822-0788
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralWALGREEN COMPANY0363-0102
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralAlbertsons Companies21130-948
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralWALGREEN COMPANY0363-0177
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-179

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