What is NDC 0121-0657?

0121-0657 is the product NDC for Acetaminophen, Acetaminophen 160 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 3 package NDCs, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acetaminophen?

230 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acetaminophen NDC 0121-0657 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0657Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0657Add 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
0121-0657-00	00121065700	10 TRAY in 1 CASE (0121-0657-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0657-05)Marketed from Aug 1, 2007
0121-0657-11	00121065711	10 TRAY in 1 CASE (0121-0657-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSEMarketed from Aug 1, 2007
0121-0657-21	00121065721	10 TRAY in 1 CASE (0121-0657-21) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSEMarketed from Aug 1, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Acetaminophen
Generic name (nonproprietary): acetaminophen
Active ingredients: Acetaminophen — 160 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 013
Marketing start: Aug 1, 2007
Listing expires: Dec 31, 2026
Identifiers: Product ID 0121-0657_1f8166c0-62db-10f8-e063-6394a90a86cfSPL ID 1f8166c0-62db-10f8-e063-6394a90a86cfSPL set ID 6ec12573-03d6-40c1-9945-d345b401e062RxCUI 307675UNII 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

N400121065700 followed by a unit qualifier and the quantity

Package 00121-0657-00. 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 Aug 12, 2024.

Indications (excerpt from the label)

Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache 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 0121-0657

What is NDC 0121-0657?: 0121-0657 is the product NDC for Acetaminophen, Acetaminophen 160 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen.
What is the active ingredient?: Acetaminophen.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetaminophen?: 230 other product NDCs are listed under this name. See all Acetaminophen 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 Acetaminophen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
acetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Amazon.com Services LLC	72288-150	72288-0150-79
Acetaminophen	Acetaminophen 10 mg/mL	Injection, SolutionIntravenous	Somerset Therapeutics, LLC	70069-871	70069-0871-10
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Walgreens	0363-9810	00363-9810-1000363-9810-2500363-9810-50+1 more
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Family Dollar, Inc.	55319-751	55319-0751-24
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	PUBLIX SUPERMARKETS, INC	41415-175	41415-0175-0541415-0175-10
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Meijer Distribution Inc	79481-0780	79481-0780-0179481-0780-0279481-0780-04
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4132	68788-4132-0168788-4132-0268788-4132-03+1 more
acetaminophen	Acetaminophen 500 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-008	87441-0008-01
Acetaminophen	Acetaminophen 160 mg/5mL	SolutionOral	Acetris Pharma Holdings, LLC	52343-555	52343-0555-12
Acetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	Granules India Limited	62207-892	62207-0892-4962207-0892-51

All 231 Acetaminophen 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
Product	Strength	Form · route	Labeler	Product NDC
Aspirin 81 mg Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	HEB	37808-246
Aspirin Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	Valu Merchandisers Company	63941-600
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREEN CO.	0363-9798
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREENS	0363-9538
Adult Low Dose Aspirin Enteric Coatedaspirin 81mg	Aspirin 81 mg/1	Tablet, Delayed releaseOral	Pharbest Pharmaceuticals, Inc.	16103-351
Good Neighbor Pharmacy Pain Reliefacetaminophen	Acetaminophen 500 mg/1	TabletOral	Amerisource Bergen	24385-484
Aspirin Regular Strengthaspirin	Aspirin 325 mg/1	Tablet, Film coatedOral	Walgreen Company	0363-0157
Kids Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	LiquidOral	Genexa Inc.	69676-0089
Aspirin 325 mgaspirin	Aspirin 325 mg/1	TabletOral	Hi-Tech Nutraceuticals, LLC	69732-008
Pharbetol Regular strengthacetaminophen	Acetaminophen 325 mg/1	TabletOral	Pharbest Pharmaceuticals, Inc.	16103-353
Cafiaspirina Rapid Headache Reliefaspirin, caffeine	Aspirin 845 mg/1.2g; Caffeine 65 mg/1.2g	PowderOral	Belmora LLC	27854-755
Back and Bodyaspirin, caffeine	Aspirin 500 mg/1; Caffeine 32.5 mg/1	Tablet, Film coatedOral	Kroger Company	30142-654
Extra Strength Acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	TIME CAP LABORATORIES, INC.	49483-697
Aphenacetaminophen	Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-372
CareOne Infants Acetaminophenacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	American Sales Company	41520-363
Extra Strength Pain Relieveracetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Walmart Inc.	79903-342
PANADOL Extraacetaminophen and caffeine	Acetaminophen 500 mg/1; Caffeine 65 mg/1	Tablet, Film coatedOral	Haleon US Holdings LLC	0135-0620
Low Dose Aspirinaspirin	Aspirin 81 mg/1	Tablet, CoatedOral	TIME CAP LABORATORIES, INC	49483-481
Pain Relief Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Capsule, Liquid filledOral	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	53345-019
Back and Body Pain Reliefaspirin, caffeine	Aspirin 500 mg/1; Caffeine 32.5 mg/1	Tablet, Film coatedOral	WinCo Foods, LLC	67091-430

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