Over-the-counter drug · ANDA

Arthritis Pain Reliever (acetaminophen) NDC 0363-9781

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · WALGREENS

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-9781Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-9781Add 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
0363-9781-0100363978101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-9781-01)Marketed from Sep 28, 2022
0363-9781-42003639781421 BOTTLE in 1 CARTON (0363-9781-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Nov 22, 2022

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, Extended release
Route
Oral
Labeler
WALGREENS
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215486
Marketing start
Listing expires
Identifiers
Product ID 0363-9781_13b1dc8a-f101-bf67-e063-6294a90a2a95SPL ID 13b1dc8a-f101-bf67-e063-6294a90a2a95SPL set ID e71f632f-37dd-49c0-e053-2a95a90a67d7RxCUI 1148399UNII 362O9ITL9D

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

N400363978101 followed by a unit qualifier and the quantity

Package 00363-9781-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 215486

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

FDA NDC Directory listings under ANDA 215486
ProductStrengthForm · routeLabelerProduct NDC
Muscle Aches and Pains Acetaminophen extended releaseacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC.49483-704
Acetaminophenacetaminophen tablet extended releaseAcetaminophen 650 mg/1Tablet, Extended releaseOralAsclemed USA, Inc.76420-914
8hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-7561
Acetaminophen Extended-Release Tablets, 650 mgacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-071
8 Hr Muscle Aches And PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-354
Acetaminophen Extended-Release Tablets, 650 mgacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-108
8HR Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTARGET CORPORATION11673-928
8HR Arthritis Pain Reliefacetaminophen 650mgAcetaminophen 650 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-969
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBETTER LIVING BRANDS, LLC21130-097
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSAM'S WEST INC68196-034
8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralLEADER/ Cardinal Health 110, Inc.70000-0733
8HR Muscle Aches and Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralLEADER/ Cardinal Health 110, Inc.70000-0734
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-704
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-699
Acetaminophenacetaminophen tablet extended releaseAcetaminophen 650 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-9746
8 hr Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDOLGENCORP, INC.55910-895
8 hr Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDOLGENCORP, INC.55910-892
Arthritis Pain AcetaminophenacetaminophenAcetaminophen 650 mg/1TabletOralTARGET CORPORATION11673-673
Acetaminophenacetaminophen tablet extended releaseAcetaminophen 650 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC.49483-699

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