Prescription drug · ANDA

Oxycodone Hydrochloride NDC 72865-128

Oxycodone hydrochloride 15 mg/1 · Tablet · Oral · XLCare Pharmaceuticals, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)72865-128Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72865-0128Add 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 NDC11-digit (billing)PackageCopy
72865-128-0172865012801100 TABLET in 1 BOTTLE (72865-128-01)Marketed from Feb 25, 2020
72865-128-0572865012805500 TABLET in 1 BOTTLE (72865-128-05)Marketed from Feb 25, 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)
Oxycodone Hydrochloride
Generic name (nonproprietary)
oxycodone hydrochloride
Active ingredients
Oxycodone hydrochloride — 15 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207418
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 72865-128_6261bbcf-f814-4219-9954-8f4662cfa9d9SPL ID 6261bbcf-f814-4219-9954-8f4662cfa9d9SPL set ID e5c8e72d-4ac5-4ca3-9557-6a659d4d8338RxCUI 1049611, 1049618UNII C1ENJ2TE6CUPC 0372865129012, 0372865128015, 0372865128053, 0372865129050
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

N472865012801 followed by a unit qualifier and the quantity

Package 72865-0128-01. 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 . 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. Oxycodone hydrochloride is an opioid agonist indicated for the m…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207418

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

FDA NDC Directory listings under ANDA 207418
ProductStrengthForm · routeLabelerProduct NDC
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralCamber Pharmaceuticals Inc31722-485
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralCamber Pharmaceuticals Inc31722-484
Oxycodone HydrochlorideOxycodone hydrochloride 20 mg/1TabletOralCamber Pharmaceuticals Inc31722-486
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralBryant Ranch Prepack63629-8890
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralBryant Ranch Prepack71335-2126
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralCamber Pharmaceuticals Inc31722-917
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralCamber Pharmaceuticals Inc31722-918
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralXLCare Pharmaceuticals, Inc72865-129
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralBryant Ranch Prepack63629-1930
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-966
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-967

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Oxycodone Hydrochloride NDC 72865-128 | Med-Code