NDC codes

FDA NDC Directory
Product NDC (as listed)53145-013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53145-0013Add 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
53145-013-71531450013715314500137130 TABLET in 1 BOTTLE (53145-013-71)Marketed from Jan 1, 2017

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)
Duralgina
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 325 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Menper Distributors Inc.NDC labeler code 53145
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 53145-013_3a893b13-e7ee-c5b1-e063-6394a90a4253SPL ID 3a893b13-e7ee-c5b1-e063-6394a90a4253SPL set ID bb31f66c-80a9-4bdb-983b-cef5d21de5ffRxCUI 313782UNII 362O9ITL9DUPC 0042279108056

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

N453145001371 followed by a unit qualifier and the quantity

Package 53145-0013-71. 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 For the temporary relief of minor aches and pains associated with headache muscular aches minor arthritis pain menstrual cramps common cold temporarily reduces fever backaches toothaches

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53145-013

What is NDC 53145-013?
53145-013 is the product NDC for Duralgina (acetaminophen), Acetaminophen 325 mg/1 tablet, listed with the FDA by Menper Distributors Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Duralgina (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Menper Distributors Inc., NDC labeler code 53145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Duralgina?
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
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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