What is NDC 81389-001?

81389-001 is the product NDC for SafeTynadol (acetaminophen), Acetaminophen 500 mg/1 tablet, coated, listed with the FDA by Sinew Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sinew Pharma Inc., NDC labeler code 81389. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for SafeTynadol?

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.

SafeTynadol NDC 81389-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)81389-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81389-0001Add 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 NDC	11-digit (billing)	Package	Copy
81389-001-01	81389000101	200 TABLET, COATED in 1 BOTTLE (81389-001-01)Marketed from Jan 21, 2021

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): SafeTynadol
Generic name (nonproprietary): acetaminophen
Active ingredients: Acetaminophen — 500 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Sinew Pharma Inc.NDC labeler code 81389
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 013
Marketing start: Jan 21, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 81389-001_08c11030-7b99-55ae-e063-6394a90a1437SPL ID 08c11030-7b99-55ae-e063-6394a90a1437SPL set ID b956d527-7ea7-e084-e053-2a95a90a866dRxCUI 198440UNII 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

N481389000101 followed by a unit qualifier and the quantity

Package 81389-0001-01. 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 Oct 28, 2023.

Indications (excerpt from the label)

Uses ￭Temporarily relieves minor aches and pains due to: ￭the common cold ￭headache ￭backache ￭minor pain of arthritis ￭muscular aches ￭toothache ￭premenstrual and menstrual cramps ￭Temporarily reduces feverr

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81389-001

What is NDC 81389-001?: 81389-001 is the product NDC for SafeTynadol (acetaminophen), Acetaminophen 500 mg/1 tablet, coated, listed with the FDA by Sinew Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: SafeTynadol (Acetaminophen).
What is the active ingredient?: Acetaminophen.
Who is the labeler?: Sinew Pharma Inc., NDC labeler code 81389. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for SafeTynadol?: 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
Product	Strength	Form · route	Labeler	Product NDC
365 whole foods market acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	Whole Foods Market, INC.	42681-0025
Acetaminophen	Acetaminophen 160 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0657
Acetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-0941
Acetaminophen	Acetaminophen 160 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1047
Acetaminophen	Acetaminophen 325 mg/10.15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1314
Acetaminophen	Acetaminophen 325 mg/10.15mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-1882
Acetaminophen	Acetaminophen 650 mg/20.3mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1971
Acetaminophen	Acetaminophen 325 mg/10.15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-2094
Acetaminophen	Acetaminophen 650 mg/20.3mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-2823
Acetaminophen	Acetaminophen 650 mg/20.3mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-3141
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREENS	0363-9538
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREEN CO.	0363-9595
Acetaminophen	Acetaminophen 160 mg/1	TabletOral	WALGREEN CO.	0363-9605
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREEN CO.	0363-9798
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Walgreens	0363-9810
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Rugby Laboratories	0536-1172
Acetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	Rugby Laboratories	0536-1292
Acetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Rugby Laboratories	0536-1413
Acetaminophen	Acetaminophen 325 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8608
Acetaminophen	Acetaminophen 325 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8609

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SafeTynadol (Acetaminophen) NDC 81389-001