Over-the-counter drug · ANDA

8 Hour Pain Relief (Acetaminophen) NDC 63941-401

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

NDC codes

FDA NDC Directory
Product NDC (as listed)63941-401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63941-0401Add 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
63941-401-0263941040102639410401021 BOTTLE, PLASTIC in 1 CARTON (63941-401-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Dec 12, 2019

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 Pain Relief
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 63941-401_45b2da7e-84d5-5b1d-e063-6394a90a0cf8SPL ID 45b2da7e-84d5-5b1d-e063-6394a90a0cf8SPL set ID d11a7412-a543-0e34-e053-2995a90afd63RxCUI 1148399UNII 362O9ITL9DUPC 0070038626671

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

N463941040102 followed by a unit qualifier and the quantity

Package 63941-0401-02. 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: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache 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 63941-401

What is NDC 63941-401?
63941-401 is the product NDC for 8 Hour Pain Relief (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by VALU MERCHANDISERS COMPANY. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
8 Hour Pain Relief (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 Pain Relief?
5 other product NDCs are listed under this name. See all 8 Hour Pain Relief 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 Pain Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-08283324-0082-50
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-70441226-0704-01
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-112370677-1123-01
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-67963868-0679-50
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-63046122-0630-7146122-0630-78

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, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-660
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARC GLASSMAN, INC.68998-401
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8624
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1123
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-629
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-630
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralGranules USA, Inc.69848-015
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMeijer41250-658
Tylenol 8 Hr Muscle Aches And PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-576
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERIFOODS TRADING COMPANY61504-200
Tylenol 8 Hr Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-575
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-401
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDISCOUNT DRUG MART53943-200
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-679
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-200
AcetaminophenAcetaminophen 650 mg/1TabletOralFAMILY DOLLAR55319-185
Acetaminophen Extended-ReleaseacetaminophenAcetaminophen 650 mg/1TabletOralMagno-Humphries, Inc.54257-573
AcetaminophenAcetaminophen 650 mg/1TabletOralWAL-MART STORES INC79903-137
AcetaminophenAcetaminophen 650 mg/1TabletOralMAJOR PHARMACEUTICALS0904-7314
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGERI-CARE PHARMACEUTICAL CORP57896-268

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