Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen NDC 0615-8397
Acetaminophen 325 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8397-30 | 0061583973000615839730 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8397-30) / 5 TABLET in 1 BLISTER PACKMarketed from Apr 26, 2021 | |
| 0615-8397-39 | 0061583973900615839739 | 30 TABLET in 1 BLISTER PACK (0615-8397-39)Marketed from Apr 26, 2021 |
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)
- Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Marketing end
- Identifiers
- Product ID 0615-8397_d48fadc8-c402-4ecd-b8af-c1ea069eac71SPL ID d48fadc8-c402-4ecd-b8af-c1ea069eac71SPL set ID bb450552-728a-4675-b0a9-0fd2934f6c5eRxCUI 313782UNII 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
N400615839730followed by a unit qualifier and the quantityPackage 00615-8397-30. 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: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0615-8397
- What is NDC 0615-8397?
- 0615-8397 is the product NDC for Acetaminophen, Acetaminophen 325 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 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?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?
- 234 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 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4787 | 70518-4787-00 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4782 | 70518-4782-0070518-4782-01 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4783 | 70518-4783-00 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-099 | 72288-0099-79 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Amazon.com Services LLC | 72288-440 | 72288-0440-09 |
| 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 |
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
Showing 20 of 40.