Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60 NDC 71679-312
acetaminophen 500mg pyrilamine maleate 15mg and caffeine 60mg tablets · Caffeine 60 mg/1; Pyrilamine maleate 15 mg/1 · Tablet, Film coated · Oral · Health Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71679-312-00 | 71679031200 | 28500 TABLET, FILM COATED in 1 BOX (71679-312-00)Marketed from Mar 7, 2024 | |
| 71679-312-20 | 71679031220 | 20 TABLET, FILM COATED in 1 BOTTLE (71679-312-20)Marketed from Mar 7, 2024 |
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 500 Pyrilamine Maleate 15 and Caffeine 60
- Generic name (nonproprietary)
- acetaminophen 500mg pyrilamine maleate 15mg and caffeine 60mg tablets
- Active ingredients
- Caffeine — 60 mg/1Pyrilamine maleate — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Health Pharma USA LLCNDC labeler code 71679
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 71679-312_56138f15-d8ff-eff5-e063-6394a90a326aSPL ID 56138f15-d8ff-eff5-e063-6394a90a326aSPL set ID 34eb8a9b-d0ee-13e8-e063-6294a90a2fefRxCUI 1597298UNII 3G6A5W338E, R35D29L3ZAUPC 0371679312207
- Pharmacologic class
- Central Nervous System Stimulant; Methylxanthine
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
N471679031200followed by a unit qualifier and the quantityPackage 71679-0312-00. 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 Uses: ■ for the temporary relief of these symptoms associated with menstrual periods: ■ cramps ■ bloating ■ water-weight gain ■ headache ■ backache ■ muscle aches ■ fatigue
Excerpt only. Read the full label for complete information.
About NDC 71679-312
- What is NDC 71679-312?
- 71679-312 is the product NDC for Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60, Caffeine 60 mg/1; Pyrilamine maleate 15 mg/1 tablet, film coated, listed with the FDA by Health Pharma USA LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60 (Acetaminophen 500mg Pyrilamine Maleate 15mg and Caffeine 60mg Tablets).
- What is the active ingredient?
- Caffeine, Pyrilamine maleate.
- Who is the labeler?
- Health Pharma USA LLC, NDC labeler code 71679. 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 500 Pyrilamine Maleate 15 and Caffeine 60?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | FSA STORE INC. | 81522-070 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6773 |
| MAX Cold, Flu, and Sore Throatacetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | LiquidOral | H E B | 37808-316 |
| CVS Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | CapsuleOral | CVS Pharmacy | 51316-185 |
| Headache Relief, Extra Strength 24/7 Life by 7-Elevenacetaminophen, aspirin, caffeine tablet, film coated | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-5641 |
| Acetaminophen , Caffeine and pyrilamine maleate | Caffeine 60 mg/1 + 2 more ingredients | CapsuleOral | Softgel Healthcare Pvt Ltd | 35916-1234 |
| Vitapirenaacetaminophen | Acetaminophen 500 mg/1 | Granule, For solutionOral | Pharmadel LLC | 55758-012 |
| Headache Relief Extra Strengthacetaminophen, aspirin and caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Salado Sales, Inc. | 57243-334 |
| pain relieveracetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1502 |
| Acetaminophen Diphenhydramine HCL | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALGREENS CO. | 0363-9664 |
| CVS Effervescent Antacid and Pain Relieveraspirin, anhydrous citric acid, sodium bicarbonate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | CVS Pharmacy | 69842-421 |
| Rugby Aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Rugby Laboratories | 0536-1008 |
| Topcare Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Topco Associates LLC | 36800-484 |
| Regular Strength Pain Relieveracetaminophen | Acetaminophen 325 mg/1 | TabletOral | INGLES MARKETS, INC. | 62936-0102 |
| Childrens Pain Relief Dye-Freeacteaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | WinCo Foods, LLC | 67091-119 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | WALGREENS CO. | 0363-1320 |
| Chewable Aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | RETAIL BUSINESS SERVICES , LLC. | 72476-205 |
| Acetaminophen PMacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | FSA STORE INC. | 81522-095 |
| Unisom PM Pain Nighttime Sleep Aid and Pain Relieveracetaminophen and diphenhydramine hydrochloride | Acetaminophen 325 mg/1; Diphenhydramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Chattem, Inc. | 41167-0040 |
| CVS Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | CapsuleOral | CVS Pharmacy | 51316-188 |
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