Over-the-counter drug · OTC MONOGRAPH DRUG

TYLENOL Extra Strength (Acetaminophen) NDC 50580-209

Acetaminophen 500 mg/.95g · Powder · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-209Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0209Add 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
50580-209-025058002090212 PACKET in 1 CARTON (50580-209-02) / .95 g in 1 PACKETMarketed from Jun 15, 2020
50580-209-045058002090432 PACKET in 1 CARTON (50580-209-04) / .95 g in 1 PACKETMarketed from Jun 15, 2020

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)
TYLENOL Extra Strength
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 500 mg/.95g
Dosage form
Powder
Route
Oral
Labeler
Kenvue Brands LLCNDC labeler code 50580
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 50580-209_3efe12ef-7f94-9548-e063-6294a90aba91SPL ID 3efe12ef-7f94-9548-e063-6294a90aba91SPL set ID ab02080a-c903-4e4a-a9f3-2b8197ed2f2bRxCUI 2374360, 2374361UNII 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

N450580020902 followed by a unit qualifier and the quantity

Package 50580-0209-02. 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.

Full label on DailyMed (opens in a new tab)

About NDC 50580-209

What is NDC 50580-209?
50580-209 is the product NDC for TYLENOL Extra Strength (acetaminophen), Acetaminophen 500 mg/.95g powder, listed with the FDA by Kenvue Brands LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TYLENOL Extra Strength (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TYLENOL Extra Strength?
24 other product NDCs are listed under this name. See all TYLENOL Extra Strength 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 TYLENOL Extra Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TYLENOL Extra StrengthacetaminophenAcetaminophen 960 mg/30mLSuspensionOralKenvue Brands LLC50580-18750580-0187-08
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Capsule, Liquid filledOralKenvue Brands LLC50580-46950580-0469-1850580-0469-4050580-0469-75
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-10850580-0108-25
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-49150580-0491-0150580-0491-1050580-0491-70
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-47250580-0472-0150580-0472-0250580-0472-03+1 more
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralR J General Corporation70264-02770264-0027-01
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralKenvue Brands LLC50580-49050580-0490-0250580-0490-1050580-0490-20+4 more
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-45750580-0457-1050580-0457-1150580-0457-70
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-546950090-5469-00
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-93750580-0937-0150580-0937-0250580-0937-06+10 more

All 25 TYLENOL Extra Strength 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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