Over-the-counter drug · ANDA

Arthritis Pain (acetaminophen) NDC 68196-034

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · SAM'S WEST INC

NDC codes

FDA NDC Directory
Product NDC (as listed)68196-034Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68196-0034Add 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
68196-034-0268196003402200 TABLET, EXTENDED RELEASE in 1 BOTTLE (68196-034-02)Marketed from Aug 20, 2025

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)
Arthritis Pain
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215486
Marketing start
Listing expires
Identifiers
Product ID 68196-034_3c156540-3319-441d-e063-6394a90adcedSPL ID 3c156540-3319-441d-e063-6394a90adcedSPL set ID 3928090d-b45e-6948-e063-6394a90a47ddRxCUI 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

N468196003402 followed by a unit qualifier and the quantity

Package 68196-0034-02. 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)

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
Arthritis Pain RelieveracetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWALGREENS0363-9781
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
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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