Over-the-counter drug · OTC MONOGRAPH DRUG

Pharbetol Regular strength (Acetaminophen) NDC 16103-353

Acetaminophen 325 mg/1 · Tablet · Oral · Pharbest Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)16103-353Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16103-0353Add 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
16103-353-0716103035307161030353071 BOTTLE, PLASTIC in 1 CARTON (16103-353-07) / 60 TABLET in 1 BOTTLE, PLASTICMarketed from Jan 9, 2007
16103-353-0816103035308161030353081 BOTTLE, PLASTIC in 1 CARTON (16103-353-08) / 100 TABLET in 1 BOTTLE, PLASTICMarketed from Jan 9, 2007
16103-353-1116103035311161030353111000 TABLET in 1 BOTTLE (16103-353-11)Marketed from Jan 9, 2007

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 Regular strengthSuffix: Regular strength
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 325 mg/1
Dosage form
Tablet
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 16103-353_c23d82e7-ab4d-4bda-b63d-cc7f96bb79f6SPL ID c23d82e7-ab4d-4bda-b63d-cc7f96bb79f6SPL set ID e0a39957-d918-4125-88f9-0e550b976fa1RxCUI 313782, 1298830UNII 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

N416103035307 followed by a unit qualifier and the quantity

Package 16103-0353-07. 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 16103-353

What is NDC 16103-353?
16103-353 is the product NDC for Pharbetol Regular strength (acetaminophen), Acetaminophen 325 mg/1 tablet, listed with the FDA by Pharbest Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pharbetol Regular strength (Acetaminophen).
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 Regular strength?
1 other product NDC are listed under this name. See all Pharbetol Regular 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 Pharbetol Regular strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pharbetol Regular strengthacetaminophenAcetaminophen 325 mg/1TabletOralATLANTIC BIOLOGICALS CORP.17856-035317856-0353-0117856-0353-04

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
AcetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralCOSTCO WHOLESALE CORPORATION63981-019
Extra Strength Pain ReleifacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralStrategic Sourcing Services, LLC70677-1242
Aspirin 81 mgaspirinAspirin 81 mg/1Tablet, Delayed releaseOralH E B37808-600
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralMorning Star OTC53209-1001
Extra Strength Pain Relieveracetaminophen tablets 500 mgAcetaminophen 500 mg/1TabletOralWALGREENS0363-0669
Pain Relieveracetaminophen capsules 500mg (minis-red opaque)Acetaminophen 500 mg/1Capsule, Liquid filledOralWalgreens0363-6684
Mommys Bliss Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralMom Enterprises, LLC.71444-793
Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralCVS Pharmacy59779-126
Good Neighbor Pharmacy childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerisource Bergen46122-211
AcetaminophenAcetaminophen 160 mg/5mLLiquidOralA-S Medication Solutions50090-6059
Members Mark AcetaminophenacetaminophenAcetaminophen 500 mg/1TabletOralSam's West Inc68196-606
Mommys Bliss Infants Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralMom Enterprises, LLC.71444-893
Thompson Extra Strength Non-AspirinacetaminophenAcetaminophen 500 mg/1TabletOralThompson73408-174
Aspirin 81 mg Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-089
AcetaminophenAcetaminophen 500 mg/1TabletOralASCLEMED USA INC.87063-222
Pain Relief Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralRite Aid Corporation11822-0600
equate pain and fever childrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWal-Mart Stores Inc49035-042
Pain and Fever ChildrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralP & L Development, LLC49580-0282
Dye Free Pain and Fever ChildrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWalgreens0363-0285
Pain Reliever Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralWalgreen Company0363-0519

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