Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen NDC 82568-0001
Acetaminophen 325 mg/1 · Tablet · Oral · AARNA USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82568-0001-1 | 82568000101 | 100 TABLET in 1 BOTTLE (82568-0001-1)Marketed from May 15, 2025 | |
| 82568-0001-2 | 82568000102 | 1000 TABLET in 1 BOTTLE (82568-0001-2)Marketed from May 15, 2025 | |
| 82568-0001-3 | 82568000103 | 100 TABLET in 1 PACKAGE (82568-0001-3)Marketed from May 15, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AARNA USA INC.NDC labeler code 82568
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 82568-0001_33f0e822-28b0-9bb2-e063-6294a90a5175SPL ID 33f0e822-28b0-9bb2-e063-6294a90a5175SPL set ID 33f0e822-28af-9bb2-e063-6294a90a5175RxCUI 313782UNII 362O9ITL9DUPC 0382568000112
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
N482568000101followed by a unit qualifier and the quantityPackage 82568-0001-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses To reduce fever and for the temporary relief of minor aches and pains due to: •headache •muscular aches •backache •minor pain of arthritis •the common cold •toothache •premenstrual and menstrual cramps. •Temporarily reduces fever.
Excerpt only. Read the full label for complete information.
About NDC 82568-0001
- What is NDC 82568-0001?
- 82568-0001 is the product NDC for Acetaminophen, Acetaminophen 325 mg/1 tablet, listed with the FDA by AARNA USA INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen.
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- AARNA USA INC., NDC labeler code 82568. 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?
- 230 other product NDCs are listed under this name. See all Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Amazon.com Services LLC | 72288-150 | 72288-0150-79 |
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-871 | 70069-0871-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 | 00363-9810-1000363-9810-2500363-9810-50+1 more |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar, Inc. | 55319-751 | 55319-0751-24 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | PUBLIX SUPERMARKETS, INC | 41415-175 | 41415-0175-0541415-0175-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Meijer Distribution Inc | 79481-0780 | 79481-0780-0179481-0780-0279481-0780-04 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4132 | 68788-4132-0168788-4132-0268788-4132-03+1 more |
| acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-008 | 87441-0008-01 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | Acetris Pharma Holdings, LLC | 52343-555 | 52343-0555-12 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules India Limited | 62207-892 | 62207-0892-4962207-0892-51 |
Other NDCs under M 013
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Aspirin 81 mg Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | HEB | 37808-246 |
| Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Valu Merchandisers Company | 63941-600 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREEN CO. | 0363-9798 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-9538 |
| Adult Low Dose Aspirin Enteric Coatedaspirin 81mg | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Pharbest Pharmaceuticals, Inc. | 16103-351 |
| Good Neighbor Pharmacy Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Amerisource Bergen | 24385-484 |
| Aspirin Regular Strengthaspirin | Aspirin 325 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0157 |
| Kids Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | Genexa Inc. | 69676-0089 |
| Aspirin 325 mgaspirin | Aspirin 325 mg/1 | TabletOral | Hi-Tech Nutraceuticals, LLC | 69732-008 |
| Pharbetol Regular strengthacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Pharbest Pharmaceuticals, Inc. | 16103-353 |
| Cafiaspirina Rapid Headache Reliefaspirin, caffeine | Aspirin 845 mg/1.2g; Caffeine 65 mg/1.2g | PowderOral | Belmora LLC | 27854-755 |
| Back and Bodyaspirin, caffeine | Aspirin 500 mg/1; Caffeine 32.5 mg/1 | Tablet, Film coatedOral | Kroger Company | 30142-654 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-697 |
| Aphenacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-372 |
| CareOne Infants Acetaminophenacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | American Sales Company | 41520-363 |
| Extra Strength Pain Relieveracetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Walmart Inc. | 79903-342 |
| PANADOL Extraacetaminophen and caffeine | Acetaminophen 500 mg/1; Caffeine 65 mg/1 | Tablet, Film coatedOral | Haleon US Holdings LLC | 0135-0620 |
| Low Dose Aspirinaspirin | Aspirin 81 mg/1 | Tablet, CoatedOral | TIME CAP LABORATORIES, INC | 49483-481 |
| Pain Relief Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Capsule, Liquid filledOral | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 53345-019 |
| Back and Body Pain Reliefaspirin, caffeine | Aspirin 500 mg/1; Caffeine 32.5 mg/1 | Tablet, Film coatedOral | WinCo Foods, LLC | 67091-430 |
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