What is NDC 72245-193?

72245-193 is the product NDC for Nalocet, Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 300 mg/1 tablet, listed with the FDA by Forte Bio-Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Nalocet (Oxycodone and acetaminophen).

What is the active ingredient?

Oxycodone hydrochloride, Acetaminophen.

Forte Bio-Pharma LLC, NDC labeler code 72245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nalocet?

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.

Nalocet NDC 72245-193 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72245-193Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72245-0193Add 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
72245-193-03	7224501930372245019303	30 TABLET in 1 BOTTLE, PLASTIC (72245-193-03)Marketed from May 23, 2018
72245-193-10	7224501931072245019310	100 TABLET in 1 BOTTLE, PLASTIC (72245-193-10)Marketed from May 23, 2018

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): Nalocet
Generic name (nonproprietary): oxycodone and acetaminophen
Active ingredients: Oxycodone hydrochloride — 2.5 mg/1Acetaminophen — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Forte Bio-Pharma LLCNDC labeler code 72245
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040608
Marketing start: May 23, 2018
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72245-193_585fcbf2-d16f-4eda-e063-6394a90a5965SPL ID 585fcbf2-d16f-4eda-e063-6394a90a5965SPL set ID f5f7dfca-a5c7-4445-8a5e-9ec62f33f5beRxCUI 1037259, 2045500UNII C1ENJ2TE6C, 362O9ITL9D
Pharmacologic class: Opioid Agonist

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

N472245019303 followed by a unit qualifier and the quantity

Package 72245-0193-03. 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 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over course of therapy [see WARNINGS ], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72245-193

What is NDC 72245-193?: 72245-193 is the product NDC for Nalocet, Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 300 mg/1 tablet, listed with the FDA by Forte Bio-Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nalocet (Oxycodone and acetaminophen).
What is the active ingredient?: Oxycodone hydrochloride, Acetaminophen.
Who is the labeler?: Forte Bio-Pharma LLC, NDC labeler code 72245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nalocet?: 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 ANDA 040608

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

FDA NDC Directory listings under ANDA 040608
Product	Strength	Form · route	Labeler	Product NDC
oxycodone and acetaminophen	Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 300 mg/1	TabletOral	FH2 Pharma LLC	72887-193
oxycodone and acetaminophenoxycodone and acetaminophen tablets	Oxycodone hydrochloride 5 mg/1; Acetaminophen 300 mg/1	TabletOral	FH2 Pharma LLC	72887-681
oxycodone and acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 300 mg/1	TabletOral	FH2 Pharma LLC	72887-682
oxycodone and acetaminophenoxycodone and acetaminophen tablets	Oxycodone hydrochloride 10 mg/1; Acetaminophen 300 mg/1	TabletOral	FH2 Pharma LLC	72887-683
Prolateoxycodone and acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 300 mg/1	TabletOral	Forte Bio-Pharma LLC	72245-681
Prolateoxycodone and acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 300 mg/1	TabletOral	Forte Bio-Pharma LLC	72245-682
Prolateoxycodone and acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 300 mg/1	TabletOral	Forte Bio-Pharma LLC	72245-683

Nalocet (Oxycodone and acetaminophen) NDC 72245-193