What is NDC 72189-255?

72189-255 is the product NDC for Oxycodone And Acetaminophen, Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by DIRECT RX. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Oxycodone hydrochloride, Acetaminophen.

DIRECT RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Oxycodone And Acetaminophen?

110 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxycodone And Acetaminophen NDC 72189-255

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-255Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0255Add 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
72189-255-30	7218902553072189025530	30 TABLET in 1 BOTTLE (72189-255-30)Marketed from Aug 10, 2021
72189-255-60	7218902556072189025560	60 TABLET in 1 BOTTLE (72189-255-60)Marketed from Aug 10, 2021

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): Oxycodone And Acetaminophen
Generic name (nonproprietary): oxycodone and acetaminophen
Active ingredients: Oxycodone hydrochloride — 10 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: DIRECT RXNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207510
Marketing start: Aug 10, 2021
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-255_36d68732-0635-1380-e063-6394a90a69c6SPL ID 36d68732-0635-1380-e063-6394a90a69c6SPL set ID a8206207-ad09-83df-e053-2995a90a78b7RxCUI 1049214, 1049225, 1049621, 1049683UNII 362O9ITL9D, C1ENJ2TE6C
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

N472189025530 followed by a unit qualifier and the quantity

Package 72189-0255-30. 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 Jun 5, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Oxycodone hydrochloride 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, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1)] , reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-255

What is NDC 72189-255?: 72189-255 is the product NDC for Oxycodone And Acetaminophen, Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by DIRECT RX. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oxycodone And Acetaminophen.
What is the active ingredient?: Oxycodone hydrochloride, Acetaminophen.
Who is the labeler?: DIRECT RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oxycodone And Acetaminophen?: 110 other product NDCs are listed under this name. See all Oxycodone And 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 Oxycodone And Acetaminophen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-898	60760-0898-3060760-0898-60
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-899	60760-0899-3060760-0899-6060760-0899-90
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-897	60760-0897-3060760-0897-60
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-368	72189-0368-3072189-0368-6072189-0368-72+1 more
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	60687-642	60687-0642-01
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-668	70010-0668-0170010-0668-05
Oxycodone and Acetaminophen	Acetaminophen 325 mg/1; Oxycodone hydrochloride 2.5 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-667	70010-0667-0170010-0667-05
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-669	70010-0669-0170010-0669-05
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-670	70010-0670-0170010-0670-05
Oxycodone And Acetaminophen	Acetaminophen 325 mg/1; Oxycodone hydrochloride 7.5 mg/1	TabletOral	DIRECT RX	72189-256	72189-0256-3072189-0256-6072189-0256-72

All 111 Oxycodone And Acetaminophen NDCs

Other NDCs under ANDA 207510

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

FDA NDC Directory listings under ANDA 207510
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone And Acetaminophen	Acetaminophen 325 mg/1; Oxycodone hydrochloride 7.5 mg/1	TabletOral	DIRECT RX	72189-256
Oxycodone And Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	87063-033
Oxycodone And Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	87063-032
Oxycodone And Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	87063-034
Oxycodone And Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-9675
Oxycodone And Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-9674
Oxycodone And Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Major Pharmaceuticals	0904-7093
Oxycodone And Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Major Pharmaceuticals	0904-7094
Oxycodone And Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2049
Oxycodone And Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Major Pharmaceuticals	0904-7095
Oxycodone And Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Eywa Pharma Inc	71930-045
Oxycodone And Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Eywa Pharma Inc	71930-046
Oxycodone And Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Eywa Pharma Inc	71930-047
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	60687-642