Over-the-counter drug · OTC MONOGRAPH DRUG

Pharbetol (Acetaminophen 500mg) NDC 16103-350

Acetaminophen 500 mg/1 · Tablet, Coated · Oral · Pharbest Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)16103-350Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16103-0350Add 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
16103-350-0416103035004161030350041 BOTTLE, PLASTIC in 1 CARTON (16103-350-04) / 30 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 2018
16103-350-0816103035008161030350081 BOTTLE, PLASTIC in 1 CARTON (16103-350-08) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 2018
16103-350-101610303501016103035010500 TABLET, COATED in 1 BOTTLE, PLASTIC (16103-350-10)Marketed from Mar 1, 2018
16103-350-1116103035011161030350111000 TABLET, COATED in 1 BOTTLE, PLASTIC (16103-350-11)Marketed from Mar 1, 2018

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)
Pharbetol
Generic name (nonproprietary)
acetaminophen 500mg
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Pharbest Pharmaceuticals, Inc.NDC labeler code 16103
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 16103-350_e22d20db-8648-409d-b8db-78c1dddfbf6aSPL ID e22d20db-8648-409d-b8db-78c1dddfbf6aSPL set ID 27337be9-e279-460e-903e-ae4463099599RxCUI 198440, 1293942UNII 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

N416103035004 followed by a unit qualifier and the quantity

Package 16103-0350-04. 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 16103-350

What is NDC 16103-350?
16103-350 is the product NDC for Pharbetol (acetaminophen 500mg), Acetaminophen 500 mg/1 tablet, coated, listed with the FDA by Pharbest Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pharbetol (Acetaminophen 500mg).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Pharbest Pharmaceuticals, Inc., NDC labeler code 16103. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pharbetol?
6 other product NDCs are listed under this name. See all Pharbetol 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 Pharbetol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pharbetolacetaminophen 500mgAcetaminophen 500 mg/1Tablet, CoatedOralUlai Health LLC73057-35073057-0350-0873057-0350-11
Pharbetolacetaminophen 325 mgAcetaminophen 325 mg/1TabletOralUlai Health LLC73057-35373057-0353-0873057-0353-11
Pharbetolacetaminophen 500mgAcetaminophen 500 mg/1TabletOralUlai Health LLC73057-37673057-0376-0873057-0376-11
PharbetolacetaminophenAcetaminophen 500 mg/1TabletOralPharbest Pharmaceuticals, Inc.16103-37616103-0376-0616103-0376-0816103-0376-11
PharbetolacetaminophenAcetaminophen 500 mg/1TabletOralProficient Rx LP71205-47871205-0478-2071205-0478-2471205-0478-30+4 more
PharbetolacetaminophenAcetaminophen 500 mg/1TabletOralProficient Rx LP71205-99071205-0990-0071205-0990-1171205-0990-50+1 more

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
Headache Relief Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTabletOralTARGET Corporation11673-686
Aspirin Low Dose ChewableaspirinAspirin 81 mg/1Tablet, ChewableOralBetter Living Brands, LLC21130-397
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralKenvue Brands LLC50580-490
MedlineacetaminophenAcetaminophen 325 mg/1TabletOralMedline Industries, LP53329-194
Acetaminophen Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralAurohealth LLC58602-748
AspirinAspirin 325 mg/1Tablet, CoatedOralMarc Glassman, Inc.68998-018
MejoralitoacetaminophenAcetaminophen 160 mg/5mLSuspensionOralOPMX Chula Vista69729-068
Ed ApapacetaminophenAcetaminophen 160 mg/5mLLiquidOralEDWARDS PHARMACEUTICALS, INC.0485-0057
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralAdvagen Pharma Limited72888-459
pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralKroger Company30142-590
equate pain relieveracetaminophenAcetaminophen 500 mg/1TabletOralWal-Mart Stores Inc49035-308
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-472
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralDISCOUNT DRUG MART53943-092
aspirinAspirin 81 mg/1Tablet, ChewableOralPublix Super Markets Inc56062-274
Acetaminophen Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralAurohealth LLC58602-745
AcetaminophenAcetaminophen 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3959
Acetaminophen, Aspirin, CaffeineCaffeine 65 mg/1 + 2 more ingredientsTablet, Film coatedOralCVS Pharmacy, Inc.69842-541
AspirinAspirin 325 mg/1Tablet, CoatedOralFSA Store Inc.81522-018
AspirinAspirin 325 mg/1Tablet, Film coatedOralProficient Rx LP82804-167
Extra Strenght Headache Reliefacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTabletOralLil' Drug Store Products, Inc.29485-6538

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