Over-the-counter drug · ANDA

arthritis pain reliever (Acetaminophen) NDC 0363-0544

Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Walgreen Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0544Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0544Add 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
0363-0544-7800363054478100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-0544-78)Marketed from Jul 31, 2014

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)
arthritis pain reliever
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Walgreen CompanyNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075077
Marketing start
Listing expires
Identifiers
Product ID 0363-0544_14730300-066e-40c6-bf1a-55993ad3b185SPL ID 14730300-066e-40c6-bf1a-55993ad3b185SPL set ID 5028c116-d0e3-4e30-8fa8-caaf08d99ec7RxCUI 1148399UNII 362O9ITL9DUPC 0311917180014

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

N400363054478 followed by a unit qualifier and the quantity

Package 00363-0544-78. 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 • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0363-0544

What is NDC 0363-0544?
0363-0544 is the product NDC for arthritis pain reliever (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Walgreen Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
arthritis pain reliever (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for arthritis pain reliever?
13 other product NDCs are listed under this name. See all arthritis pain reliever 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 arthritis pain reliever NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
arthritis pain relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalHyVee Inc42507-15042507-0150-01
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalPublix Super Markets Inc56062-47156062-0471-02
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalH E B59640-19859640-0198-0159640-0198-0259640-0198-03
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalQUALITY CHOICE (Chain Drug Marketing Association)83324-30683324-0306-01
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalFamily Dollar (FAMILY WELLNESS)55319-96955319-0969-17
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-75246122-0752-3746122-0752-5246122-0752-53
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalChain Drug Consortium, LLC68016-17168016-0171-0068016-0171-50
Arthritis Pain RelieveracetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWALGREENS0363-978100363-9781-0100363-9781-42
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCVS PHARMACY, INC51316-01251316-0012-15
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCVS PHARMACY, INC51316-07351316-0073-76

All 14 arthritis pain reliever NDCs

Other NDCs under ANDA 075077

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

FDA NDC Directory listings under ANDA 075077
ProductStrengthForm · routeLabelerProduct NDC
8 hr arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-504
acetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-150
Acetaminophen 650mgacetaminophenAcetaminophen 650 mg/1TabletOralForreal Pharmaceuticals, LLC81877-850
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-966
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-544
basic care acetaminophenacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-544
basic care acetaminophenacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-634
Care One arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmerican Sales Company41520-544
CareOne 8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmerican Sales Company41520-127
DG Health 8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralDolgencorp Inc55910-749
dg health 8 hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralDolgencorp Inc55910-828
Equate 8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWal-Mart Stores Inc49035-741
equate 8hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-345
Equate Menstrual Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-420
Good Neighbor Pharmacy Menstrual Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmerisource Bergen46122-836
Good Sense Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0044
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0544
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2545
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralASCLEMED USA INC.76420-590
Leader 8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0736

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