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 |
|---|---|---|---|
| 0615-8397-05 | 00615839705 | 15 TABLET in 1 BLISTER PACK (0615-8397-05)Marketed from Nov 15, 2022 | |
| 0615-8397-30 | 00615839730 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8397-30) / 5 TABLET in 1 BLISTER PACKMarketed from Apr 26, 2021 | |
| 0615-8397-39 | 00615839739 | 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
- 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
N400615839705followed by a unit qualifier and the quantityPackage 00615-8397-05. 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.
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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| berries and cream hand sanitizeralcohol | Alcohol .62 mL/mL | GelTopical | Target Corporation | 11673-785 |
| Safeguard Hand Sanitizeralcohol | Alcohol 64 g/100mL | GelTopical | The Procter & Gamble Manufacturing Company | 37000-603 |
| Hand Washbenzalkonium chloride | Benzalkonium chloride 1.3 mg/mL | LiquidTopical | Demoulas Super Markets, Inc | 53942-466 |
| Dial Professional Antibacterial Defense Spring Waterbenzalkonium chloride | Benzalkonium chloride .13 g/100mL | SolutionTopical | Henkel Corporation | 54340-121 |
| CVS Antisepticcetylpyridinium chloride | Cetylpyridinium chloride .7 mg/mL | RinseOral | CVS Pharmacy, Inc. | 59779-299 |
| Anti Bacterial Hand Gel Winteralcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6957 |
| Anti Bacterial Hand Gel Black Cherry Merlotalcohol | Alcohol 71 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6693 |
| Antibacterial Foaming Skin Cleanserbenzalkonium chloride | Benzalkonium chloride .13 mg/mL | SoapTopical | Betco Corporation, Ltd. | 65601-709 |
| Hawthorn Hygiene Solutions ENERGY ANTIBACTERIAL FOAM FRAGRANCE FREE 1200 mLbenzalkonium chloride | Benzalkonium chloride .0013 mg/mL | LiquidTopical | BUNZL Distribution | 66294-114 |
| PRO-LINK Free Hands Antibacterial Foam So apchloroxylenol | Chloroxylenol .003 mg/mL | LiquidTopical | Pro-Link, Inc. | 66908-081 |
| B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris Scentedalcohol | Alcohol 70 mL/100mL | LiquidTopical | Fourstar Group USA, Inc. | 80684-227 |
| Fresh Feels Hand Sanitizer Mist Seashell Sunshine Scentethyl alcohol | Alcohol 70 mL/100mL | SprayTopical | Amber Glow Cosmetics Limited | 87302-202 |
| Sparkling Cranberry Hand Sanitizeralcohol | Alcohol .62 mL/mL | GelTopical | Target Corporation | 11673-782 |
| Safeguard Antibacterial Foamingbenzalkonium chloride | Benzalkonium chloride .12 g/100mL | SoapTopical | The Procter & Gamble Manufacturing Company | 37000-601 |
| Advanced Hand Sanitizeralcohol | Alcohol 70 mL/100mL | GelTopical | Salado Sales Inc. | 57243-370 |
| Anti Bacterial Moisturizing Hand Sanitizer Winter Citrus Wreathalcohol | Alcohol 70 mL/100mL | GelTopical | Bath & Body Works, Inc. | 62670-6954 |
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