Over-the-counter drug · ANDA

8hr arthritis pain relief (Acetaminophen) NDC 0904-7561

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7561Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7561Add 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
0904-7561-600090475616000904756160100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-7561-60)Marketed from May 6, 2025

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)
8hr arthritis pain relief
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215486
Marketing start
Listing expires
Identifiers
Product ID 0904-7561_34388d07-02d7-72f3-e063-6294a90a6901SPL ID 34388d07-02d7-72f3-e063-6294a90a6901SPL set ID 31b3aaa2-8af2-670a-e063-6394a90a8003RxCUI 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

N400904756160 followed by a unit qualifier and the quantity

Package 00904-7561-60. 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 0904-7561

What is NDC 0904-7561?
0904-7561 is the product NDC for 8hr arthritis pain relief (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
8hr arthritis pain relief (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for 8hr arthritis pain relief?
2 other product NDCs are listed under this name. See all 8hr arthritis 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 8hr arthritis pain relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
8HR Arthritis Pain Reliefacetaminophen 650mgAcetaminophen 650 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-96951316-0969-01
8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralLEADER/ Cardinal Health 110, Inc.70000-073370000-0733-0170000-0733-02

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
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-704
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-699
8HR Arthritis Pain Reliefacetaminophen 650mgAcetaminophen 650 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-969
8HR Muscle Aches and Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralLEADER/ Cardinal Health 110, Inc.70000-0734
Acetaminophenacetaminophen tablet extended releaseAcetaminophen 650 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC.49483-699
Muscle Aches and Pains Acetaminophen extended releaseacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTIME CAP LABORATORIES, INC.49483-704
Arthritis Pain RelieveracetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWALGREENS0363-9781
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSAM'S WEST INC68196-034
Acetaminophen Extended-Release Tablets, 650 mgacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-071
8 hr Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDOLGENCORP, INC.55910-892
Acetaminophen Extended-Release Tablets, 650 mgacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-108
8 hr Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDOLGENCORP, INC.55910-895
8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralLEADER/ Cardinal Health 110, Inc.70000-0733
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBETTER LIVING BRANDS, LLC21130-097
8HR Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTARGET CORPORATION11673-928
Acetaminophenacetaminophen tablet extended releaseAcetaminophen 650 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-9746
Acetaminophenacetaminophen tablet extended releaseAcetaminophen 650 mg/1Tablet, Extended releaseOralAsclemed USA, Inc.76420-914
8 Hr Muscle Aches And PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCVS Pharmacy51316-354
Arthritis Pain AcetaminophenacetaminophenAcetaminophen 650 mg/1TabletOralTARGET CORPORATION11673-673

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