NDC codes

FDA NDC Directory
Product NDC (as listed)71679-312Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71679-0312Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71679-312-007167903120028500 TABLET, FILM COATED in 1 BOX (71679-312-00)Marketed from Mar 7, 2024
71679-312-207167903122020 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

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

N471679031200 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under M 013
ProductStrengthForm · routeLabelerProduct NDC
Acetaminophen Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralFSA STORE INC.81522-070
AcetaminophenAcetaminophen 325 mg/1TabletOralMajor Pharmaceuticals0904-6773
MAX Cold, Flu, and Sore Throatacetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hclAcetaminophen 650 mg/20mL + 3 more ingredientsLiquidOralH E B37808-316
CVS AcetaminophenacetaminophenAcetaminophen 500 mg/1CapsuleOralCVS Pharmacy51316-185
Headache Relief, Extra Strength 24/7 Life by 7-Elevenacetaminophen, aspirin, caffeine tablet, film coatedAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralLil' Drug Store Products, Inc.66715-5641
Acetaminophen , Caffeine and pyrilamine maleateCaffeine 60 mg/1 + 2 more ingredientsCapsuleOralSoftgel Healthcare Pvt Ltd35916-1234
VitapirenaacetaminophenAcetaminophen 500 mg/1Granule, For solutionOralPharmadel LLC55758-012
Headache Relief Extra Strengthacetaminophen, aspirin and caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralSalado Sales, Inc.57243-334
pain relieveracetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralWalgreen Company0363-1502
Acetaminophen Diphenhydramine HCLAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1TabletOralWALGREENS CO.0363-9664
CVS Effervescent Antacid and Pain Relieveraspirin, anhydrous citric acid, sodium bicarbonateAspirin 325 mg/1 + 2 more ingredientsTablet, EffervescentOralCVS Pharmacy69842-421
Rugby AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralRugby Laboratories0536-1008
Topcare Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralTopco Associates LLC36800-484
Regular Strength Pain RelieveracetaminophenAcetaminophen 325 mg/1TabletOralINGLES MARKETS, INC.62936-0102
Childrens Pain Relief Dye-FreeacteaminophenAcetaminophen 160 mg/5mLSuspensionOralWinCo Foods, LLC67091-119
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgAcetaminophen 250 mg/1 + 2 more ingredientsTabletOralWALGREENS CO.0363-1320
Chewable AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralRETAIL BUSINESS SERVICES , LLC.72476-205
Acetaminophen PMacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralFSA STORE INC.81522-095
Unisom PM Pain Nighttime Sleep Aid and Pain Relieveracetaminophen and diphenhydramine hydrochlorideAcetaminophen 325 mg/1; Diphenhydramine hydrochloride 50 mg/1Tablet, Film coatedOralChattem, Inc.41167-0040
CVS AcetaminophenacetaminophenAcetaminophen 500 mg/1CapsuleOralCVS Pharmacy51316-188

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