What is NDC 72245-648?

72245-648 is the product NDC for Prolate, Oxycodone hydrochloride 10 mg/5mL; Acetaminophen 300 mg/5mL solution, 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?

Prolate (Oxycodone hydrochloride 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 Prolate?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prolate NDC 72245-648 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72245-648Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72245-0648Add 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
72245-648-12	7224506481272245064812	120 mL in 1 BOTTLE, PLASTIC (72245-648-12)Marketed from Mar 1, 2020
72245-648-50	7224506485072245064850	500 mL in 1 BOTTLE, PLASTIC (72245-648-50)Marketed from Mar 1, 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): Prolate
Generic name (nonproprietary): oxycodone hydrochloride and acetaminophen
Active ingredients: Oxycodone hydrochloride — 10 mg/5mLAcetaminophen — 300 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Forte Bio-Pharma LLCNDC labeler code 72245
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202142
Marketing start: Mar 1, 2020
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72245-648_57acdd59-91c5-340c-e063-6394a90a2eddSPL ID 57acdd59-91c5-340c-e063-6394a90a2eddSPL set ID 9d75ad3b-bc9b-0c22-e053-2a95a90ac71eRxCUI 2105822, 2281851UNII C1ENJ2TE6C, 362O9ITL9DUPC 0372245648126
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

N472245064812 followed by a unit qualifier and the quantity

Package 72245-0648-12. 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 Jul 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxycodone hydrochloride and acetaminophen oral solution is 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 the course of therapy [see WARNINGS ], reserve opioid analgesics, including oxycodone hydrochloride and acetaminophen oral solution, 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 72245-648

What is NDC 72245-648?: 72245-648 is the product NDC for Prolate, Oxycodone hydrochloride 10 mg/5mL; Acetaminophen 300 mg/5mL solution, 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?: Prolate (Oxycodone hydrochloride 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 Prolate?: 3 other product NDCs are listed under this name. See all Prolate 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 Prolate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prolateoxycodone and acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 300 mg/1	TabletOral	Forte Bio-Pharma LLC	72245-681	72245-0681-0372245-0681-10
Prolateoxycodone and acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 300 mg/1	TabletOral	Forte Bio-Pharma LLC	72245-682	72245-0682-0372245-0682-10
Prolateoxycodone and acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 300 mg/1	TabletOral	Forte Bio-Pharma LLC	72245-683	72245-0683-0372245-0683-10

Other NDCs under ANDA 202142

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

FDA NDC Directory listings under ANDA 202142
Product	Strength	Form · route	Labeler	Product NDC
oxycodone hydrochloride and acetaminophen	Oxycodone hydrochloride 10 mg/5mL; Acetaminophen 300 mg/5mL	SolutionOral	FH2 Pharma LLC	72887-648