What is NDC 72189-375?

72189-375 is the product NDC for Oxycodone/APAP, Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 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/APAP?

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.

Oxycodone/APAP NDC 72189-375 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-375Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0375Add 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
72189-375-30	7218903753072189037530	30 TABLET in 1 BOTTLE (72189-375-30)Marketed from Sep 9, 2022
72189-375-60	7218903756072189037560	60 TABLET in 1 BOTTLE (72189-375-60)Marketed from Sep 9, 2022
72189-375-72	7218903757272189037572	120 TABLET in 1 BOTTLE (72189-375-72)Marketed from Sep 9, 2022
72189-375-90	7218903759072189037590	90 TABLET in 1 BOTTLE (72189-375-90)Marketed from Sep 9, 2022

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/APAP
Generic name (nonproprietary): oxycodone/apap
Active ingredients: Oxycodone hydrochloride — 7.5 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 201278
Marketing start: Sep 9, 2022
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-375_4c4c55ca-eef7-8b39-e063-6294a90adf3fSPL ID 4c4c55ca-eef7-8b39-e063-6294a90adf3fSPL set ID e84245ca-957f-e85b-e053-2a95a90a836bRxCUI 1049225UNII 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

N472189037530 followed by a unit qualifier and the quantity

Package 72189-0375-30. 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 Mar 5, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Oxycodone and Acetaminophen Tablets, USP 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], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] 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 72189-375

What is NDC 72189-375?: 72189-375 is the product NDC for Oxycodone/APAP, Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oxycodone/APAP.
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/APAP?: 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 201278

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

FDA NDC Directory listings under ANDA 201278
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1492
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-824
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-898
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1909
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-9501
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	RedPharm Drug	67296-1937
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-136
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-209
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-8876
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1338
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1339
Percocetoxycodone/apap	Acetaminophen 325 mg/1; Oxycodone hydrochloride 10 mg/1	TabletOral	Direct_Rx	72189-397
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1420
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-102
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-103
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-104
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1472