Over-the-counter drug · ANDA
Acetaminophen NDC 58602-848
Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-848-17 | 58602084817 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-17)Marketed from May 21, 2026 | |
| 58602-848-40 | 58602084840 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-40)Marketed from May 21, 2026 | |
| 58602-848-44 | 58602084844 | 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-44)Marketed from May 21, 2026 |
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)
- Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 650 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207229
- Marketing start
- Listing expires
- Identifiers
- Product ID 58602-848_32dce6fb-bdc3-454f-877f-e084d81a0872SPL ID 32dce6fb-bdc3-454f-877f-e084d81a0872SPL set ID e072e4ab-669d-40ee-b301-0bc15b67792fRxCUI 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
N458602084817followed by a unit qualifier and the quantityPackage 58602-0848-17. 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.
About NDC 58602-848
- What is NDC 58602-848?
- 58602-848 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by Aurohealth LLC. 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?
- Aurohealth LLC, NDC labeler code 58602. 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?
- 228 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 | PUBLIX SUPERMARKETS, INC | 41415-175 | 41415-0175-0541415-0175-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar, Inc. | 55319-751 | 55319-0751-24 |
| 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 ANDA 207229
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 |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-9604 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Better Living Brands, LLC | 21130-108 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-157 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-730 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-873 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | American Health Packaging | 60687-924 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | BluePoint Laboratories | 68001-495 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-037 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-635 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | WALMART INC. | 79903-132 |
| Amazon Basic Care Acetaminophenacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-698 |