What is NDC 72189-095?

72189-095 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 5 mg/1 tablet, listed with the FDA by DIRECT RX. It has 3 package NDCs, shown above in 10- and 11-digit form.

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 Hydrochloride?

130 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxycodone Hydrochloride NDC 72189-095

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-095Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0095Add 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
72189-095-30	7218900953072189009530	30 TABLET in 1 BOTTLE (72189-095-30)Marketed from Jun 15, 2020
72189-095-60	7218900956072189009560	60 TABLET in 1 BOTTLE (72189-095-60)Marketed from Jun 15, 2020
72189-095-90	7218900959072189009590	90 TABLET in 1 BOTTLE (72189-095-90)Marketed from Jun 15, 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 — 5 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 204021
Marketing start: Jun 15, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-095_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

N472189009530 followed by a unit qualifier and the quantity

Package 72189-0095-30. 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 72189-095

What is NDC 72189-095?: 72189-095 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 5 mg/1 tablet, listed with the FDA by DIRECT RX. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oxycodone Hydrochloride.
What is the active ingredient?: Oxycodone hydrochloride.
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 Hydrochloride?: 130 other product NDCs are listed under this name. See all Oxycodone Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-967	60760-0967-3060760-0967-60
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-966	60760-0966-3060760-0966-60
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Camber Pharmaceuticals Inc	31722-484	31722-0484-0131722-0484-05
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	Camber Pharmaceuticals Inc	31722-485	31722-0485-0131722-0485-05
Oxycodone Hydrochloride	Oxycodone hydrochloride 20 mg/1	TabletOral	Camber Pharmaceuticals Inc	31722-486	31722-0486-0131722-0486-05
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-954	60760-0954-3060760-0954-60
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-956	60760-0956-3060760-0956-6060760-0956-90
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Strides Pharma Science Limited	64380-259	64380-0259-0164380-0259-02
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	Strides Pharma Science Limited	64380-260	64380-0260-01
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	Strides Pharma Science Limited	64380-261	64380-0261-0164380-0261-02

All 131 Oxycodone Hydrochloride NDCs

Other NDCs under ANDA 204021

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

FDA NDC Directory listings under ANDA 204021
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-430
Oxycodone Hydrochloride	Oxycodone hydrochloride 30 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-431
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-432
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-433
Oxycodone Hydrochloride	Oxycodone hydrochloride 20 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-434