What is NDC 63323-434?

63323-434 is the product NDC for Acetaminophen, Acetaminophen 10 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. 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?

228 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Yes: J0131, Injection, acetaminophen, 10 mg.

Acetaminophen NDC 63323-434 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-434Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0434Add 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
63323-434-00	63323043400	20 BAG in 1 CASE (63323-434-00) / 100 mL in 1 BAG (63323-434-41)Marketed from Dec 6, 2020

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): Acetaminophen
Generic name (nonproprietary): acetaminophen
Active ingredients: Acetaminophen — 10 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 204767
Marketing start: Dec 6, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 63323-434_be958bb9-95c1-4525-a145-f1372f08f978SPL ID be958bb9-95c1-4525-a145-f1372f08f978SPL set ID a0cece43-256e-4adc-92f8-11a0f473bb83RxCUI 483017UNII 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 codeMed-Code curated

J0131 — Injection, acetaminophen, 10 mg

Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323043400 followed by a unit qualifier and the quantity

Package 63323-0434-00. 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 Apr 24, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients 2 years and older. Acetaminophen Injection is indicated for the Management of mild to moderate pain in adult and pediatric patients 2 years and older ( 1 ) Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older ( 1 ) Reduction of fever in adult and pediatric patients 2 years and older ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-434

What is NDC 63323-434?: 63323-434 is the product NDC for Acetaminophen, Acetaminophen 10 mg/mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, 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?: Fresenius Kabi USA, LLC, NDC labeler code 63323. 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?: 228 other product NDCs are listed under this name. See all Acetaminophen NDCs.
Is there a related HCPCS / J-code?: Yes: J0131, Injection, acetaminophen, 10 mg. 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	PUBLIX SUPERMARKETS, INC	41415-175	41415-0175-0541415-0175-10
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Family Dollar, Inc.	55319-751	55319-0751-24
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 229 Acetaminophen NDCs