Over-the-counter drug · ANDA

Acetaminophen Extended-Release Tablets, 650 mg (Acetaminophen) NDC 25000-108

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · MARKSANS PHARMA LIMITED

NDC codes

FDA NDC Directory
Product NDC (as listed)25000-108Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25000-0108Add 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
25000-108-0225000010802250000108021 BOTTLE in 1 CARTON (25000-108-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Oct 14, 2022
25000-108-0825000010808250000108081 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Oct 14, 2022

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

Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
MARKSANS PHARMA LIMITEDNDC labeler code 25000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215486
Marketing start
Listing expires
Identifiers
Product ID 25000-108_9e2c09cd-1bd4-4a86-8911-ba904d8a76cbSPL ID 9e2c09cd-1bd4-4a86-8911-ba904d8a76cbSPL set ID d973a910-5fe0-4a85-884d-2c3987836691RxCUI 1148399UNII 362O9ITL9DUPC 0325000071110, 0325000108021, 0325000071028, 0325000071103, 0325000108083, 0325000071080, 0325000071455

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

N425000010802 followed by a unit qualifier and the quantity

Package 25000-0108-02. 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 Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain 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. Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain 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 25000-108

What is NDC 25000-108?
25000-108 is the product NDC for Acetaminophen Extended-Release Tablets, 650 mg, Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by MARKSANS PHARMA LIMITED. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acetaminophen Extended-Release Tablets, 650 mg (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
MARKSANS PHARMA LIMITED, NDC labeler code 25000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetaminophen Extended-Release Tablets, 650 mg?
1 other product NDC are listed under this name. See all Acetaminophen Extended-Release Tablets, 650 mg 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 Acetaminophen Extended-Release Tablets, 650 mg NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Acetaminophen Extended-Release Tablets, 650 mgacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARKSANS PHARMA LIMITED25000-07125000-0071-0225000-0071-0825000-0071-10+2 more

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
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
8hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMajor Pharmaceuticals0904-7561
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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