What is NDC 72865-116?

72865-116 is the product NDC for Oxycodone And Acetaminophen, Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by XLCare Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Oxycodone hydrochloride, Acetaminophen.

XLCare Pharmaceuticals, Inc., NDC labeler code 72865. 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 72865-116

NDC codes

FDA NDC Directory

Product NDC (as listed)72865-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72865-0116Add 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
72865-116-01	7286501160172865011601	100 TABLET in 1 BOTTLE (72865-116-01)Marketed from Mar 15, 2019
72865-116-05	7286501160572865011605	500 TABLET in 1 BOTTLE (72865-116-05)Marketed from Mar 15, 2019

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: XLCare Pharmaceuticals, Inc.NDC labeler code 72865
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207419
Marketing start: Apr 11, 2017
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72865-116_9194f464-1cd1-44ac-8758-ae96b6643d5eSPL ID 9194f464-1cd1-44ac-8758-ae96b6643d5eSPL set ID 7f3c6dd7-6bc8-450e-aded-997f9cf63a8fRxCUI 1049214, 1049221, 1049225, 1049635UNII 362O9ITL9D, C1ENJ2TE6CUPC 0372865113059, 0372865116050, 0372865113011, 0372865115053, 0372865115015, 0372865114056, 0372865116012, 0372865114018
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

N472865011601 followed by a unit qualifier and the quantity

Package 72865-0116-01. 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 Feb 12, 2024. 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, and misuse, with opioids, which can occur at any dosage or duration [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 Oxycodone and Acetaminophen Tablets should not be used for an extended peri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72865-116

What is NDC 72865-116?: 72865-116 is the product NDC for Oxycodone And Acetaminophen, Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by XLCare Pharmaceuticals, Inc.. 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?: XLCare Pharmaceuticals, Inc., NDC labeler code 72865. 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 207419

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

FDA NDC Directory listings under ANDA 207419
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone And Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	61919-871
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	71205-486
Oxycodone And Acetaminophen	Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-113
Oxycodone And Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-114
Oxycodone And Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-115
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1953
Oxycodone And Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1959
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5054
Oxycodone And Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-8834
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-193
Oxycodone and Acetaminophen	Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-191
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-192
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-194
Oxycodone And Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-949
Oxycodone And Acetaminophen	Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-948
Oxycodone And Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-950
Oxycodone And Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-951
Oxycodone And Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2041
Oxycodone And Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-8888
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-368

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