Over-the-counter drug · ANDA

8 Hour Arthritis Pain (Acetaminophen) NDC 63941-300

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · VALU MERCHANDISERS COMPANY

NDC codes

FDA NDC Directory
Product NDC (as listed)63941-300Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63941-0300Add 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
63941-300-02639410300021 BOTTLE, PLASTIC in 1 CARTON (63941-300-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Jan 1, 2020
63941-300-0463941030004100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63941-300-04)Marketed from Jan 1, 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)
8 Hour Arthritis Pain
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
VALU MERCHANDISERS COMPANYNDC labeler code 63941
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Marketing end
Identifiers
Product ID 63941-300_45b2cc20-7f75-c27a-e063-6294a90a4ea3SPL ID 45b2cc20-7f75-c27a-e063-6294a90a4ea3SPL set ID cd3a7094-ddb5-4583-a1bc-dc6ce280418cRxCUI 1148399UNII 362O9ITL9DUPC 0070038597056

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

N463941030002 followed by a unit qualifier and the quantity

Package 63941-0300-02. 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 63941-300

What is NDC 63941-300?
63941-300 is the product NDC for 8 Hour Arthritis Pain (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by VALU MERCHANDISERS COMPANY. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
8 Hour Arthritis Pain (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
VALU MERCHANDISERS COMPANY, NDC labeler code 63941. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for 8 Hour Arthritis Pain?
3 other product NDCs are listed under this name. See all 8 Hour Arthritis Pain 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 8 Hour Arthritis Pain NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-08383324-0083-0183324-0083-50
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARC GLASSMAN, INC.68998-40168998-0401-03
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-62946122-0629-6246122-0629-7146122-0629-78+1 more

Other NDCs under ANDA 211544

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

FDA NDC Directory listings under ANDA 211544
ProductStrengthForm · routeLabelerProduct NDC
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWAL-MART STORES INC49035-181
eight hour pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralUnited Natural Foods, Inc. dba UNFI41163-203
AcetaminophenAcetaminophen 650 mg/1TabletOralWAL-MART STORES INC79903-137
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBi-Mart37835-512
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC36800-632
AcetaminophenAcetaminophen 650 mg/1TabletOralLEADER/ Cardinal Health 110, Inc70000-0626
AcetaminophenAcetaminophen 650 mg/1TabletOralLEADER/ Cardinal Health 110, Inc70000-0627
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1123
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-200
Tylenol 8 Hr Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-575
AcetaminophenAcetaminophen 650 mg/1TabletOralMEIJER DISTRIBUTION INC79481-0183
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGrocery Outlet, Inc.85828-200
Tylenol 8 Hr Muscle Aches And PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-576
AcetaminophenAcetaminophen 650 mg/1TabletOralMEIJER, INC.79481-0184
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERIFOODS TRADING COMPANY61504-200
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDISCOUNT DRUG MART53943-200
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-401
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralGranules USA, Inc.69848-015
AcetaminophenAcetaminophen 650 mg/1TabletOralFAMILY DOLLAR55319-185
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-401

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