Acetaminophen NDC 68083-648 · J-Code J0131

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-648Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0648Add 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
68083-648-01	68083064801	24 BAG in 1 CARTON (68083-648-01) / 100 mL in 1 BAGMarketed from Apr 2, 2025

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, Solution
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219215
Marketing start: Apr 2, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 68083-648_04cdb516-3f83-45c4-a608-6a08b1fb6cf0SPL ID 04cdb516-3f83-45c4-a608-6a08b1fb6cf0SPL set ID db5d4cf8-762a-4111-971e-91c704bc3643RxCUI 483017, 2480095UNII 362O9ITL9DUPC 0368083647018, 0368083648015

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

N468083064801 followed by a unit qualifier and the quantity

Package 68083-0648-01. 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 Apr 4, 2025. 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. 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 ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219215

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 219215
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen	Acetaminophen 10 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-647
Acetaminophen	Acetaminophen 10 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-705