Over-the-counter drug · OTC MONOGRAPH DRUG

Pain Reliever (Acetaminophen) NDC 68016-543

Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Chain Drug Consortium

NDC codes

FDA NDC Directory
Product NDC (as listed)68016-543Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68016-0543Add 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
68016-543-01680160543011 BOTTLE, PLASTIC in 1 CARTON (68016-543-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Apr 29, 2022
68016-543-24680160543241 BOTTLE, PLASTIC in 1 CARTON (68016-543-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Apr 29, 2022
68016-543-99680160543991 BOTTLE, PLASTIC in 1 CARTON (68016-543-99) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Apr 29, 2022

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)
Pain Reliever
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Chain Drug ConsortiumNDC labeler code 68016
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Marketing end
Identifiers
Product ID 68016-543_913edec4-45ba-48bd-8da0-23f38da8fd6aSPL ID 913edec4-45ba-48bd-8da0-23f38da8fd6aSPL set ID 60d4b392-6ed0-4115-8154-24eaf72504a5RxCUI 198440UNII 362O9ITL9DUPC 0840986037382

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

N468016054301 followed by a unit qualifier and the quantity

Package 68016-0543-01. 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: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68016-543

What is NDC 68016-543?
68016-543 is the product NDC for Pain Reliever (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by Chain Drug Consortium. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pain Reliever (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Chain Drug Consortium, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pain Reliever?
37 other product NDCs are listed under this name. See all Pain Reliever NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pain Reliever NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pain RelieveracetaminophenAcetaminophen 500 mg/1Chewable gelOralOrelli Inc.87780-23687780-0236-50
Pain RelieveracetaminophenAcetaminophen 500 mg/1Chewable gelOralP & L Development, LLC59726-11359726-0113-05
Pain RelieveracetaminophenAcetaminophen 500 mg/1Chewable gelOralWalgreens0363-923500363-9235-05
Pain RelieveracetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralWALGREENS0363-677900363-6779-0100363-6779-42
Pain RelieveracetaminophenAcetaminophen 500 mg/1TabletOralWALGREENS0363-113700363-1137-5300363-1137-74
Pain RelieveracetaminophenAcetaminophen 500 mg/1TabletOralShield Pharmaceuticals Corp83059-010383059-0103-05
Pain RelieveracetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralHealth Pharma USA LLC71679-30471679-0304-00
Pain RelieveracetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralHHH Pharmaceuticals83586-10783586-0107-01
Pain Relieveracetaminophen capsules 500mg (minis-red opaque)Acetaminophen 500 mg/1Capsule, Liquid filledOralWalgreens0363-668400363-6684-50
Pain Relieveraspirin 81 mgAspirin 81 mg/1Tablet, Delayed releaseOralHealth Pharma USA, LLC71679-104—

All 38 Pain Reliever NDCs

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
365 whole foods market acetaminophenacetaminophenAcetaminophen 500 mg/1TabletOralWhole Foods Market, INC.42681-0025
AcetaminophenAcetaminophen 160 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-0657
AcetaminophenAcetaminophen 160 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-0941
AcetaminophenAcetaminophen 160 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-1047
AcetaminophenAcetaminophen 325 mg/10.15mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-1314
AcetaminophenAcetaminophen 325 mg/10.15mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-1882
AcetaminophenAcetaminophen 650 mg/20.3mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-1971
AcetaminophenAcetaminophen 325 mg/10.15mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-2094
AcetaminophenAcetaminophen 650 mg/20.3mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-2823
AcetaminophenAcetaminophen 650 mg/20.3mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-3141
AcetaminophenAcetaminophen 500 mg/1TabletOralWALGREENS0363-9538
AcetaminophenAcetaminophen 500 mg/1TabletOralWALGREEN CO.0363-9595
AcetaminophenAcetaminophen 160 mg/1TabletOralWALGREEN CO.0363-9605
AcetaminophenAcetaminophen 500 mg/1TabletOralWALGREEN CO.0363-9798
AcetaminophenAcetaminophen 500 mg/1TabletOralWalgreens0363-9810
AcetaminophenAcetaminophen 500 mg/1TabletOralRugby Laboratories0536-1172
AcetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralRugby Laboratories0536-1292
AcetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralRugby Laboratories0536-1413
AcetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8608
AcetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8609

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