What is NDC 64380-261?

64380-261 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 15 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Strides Pharma Science Limited, NDC labeler code 64380. 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 64380-261

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-261Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0261Add 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
64380-261-01	6438002610164380026101	100 TABLET in 1 BOTTLE, PLASTIC (64380-261-01)Marketed from Sep 10, 2024
64380-261-02	6438002610264380026102	500 TABLET in 1 BOTTLE, PLASTIC (64380-261-02)Marketed from Sep 10, 2024

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
Labeler: Strides Pharma Science LimitedNDC labeler code 64380
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077712
Marketing start: Sep 10, 2024
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 64380-261_226ed432-8e6c-4de6-840c-55c6379f9064SPL ID 226ed432-8e6c-4de6-840c-55c6379f9064SPL set ID f3116ebf-d72c-4e98-aa50-006be4770c86RxCUI 1049611, 1049618, 1049621, 1049683, 1049686UNII C1ENJ2TE6CUPC 0364380262015, 0364380260011, 0364380259015, 0364380261018, 0364380263012
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

N464380026101 followed by a unit qualifier and the quantity

Package 64380-0261-01. 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 Jan 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Oxycodone hydrochloride is 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 and Precautions (5.1)] , reserve oxycodone hydrochloride 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 should not be used for an extended period of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-261

What is NDC 64380-261?: 64380-261 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 15 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 2 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?: Strides Pharma Science Limited, NDC labeler code 64380. 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 20 mg/1	TabletOral	Strides Pharma Science Limited	64380-262	64380-0262-01

All 131 Oxycodone Hydrochloride NDCs

Other NDCs under ANDA 077712

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

FDA NDC Directory listings under ANDA 077712
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone HCL	Oxycodone hydrochloride 20 mg/1	TabletOral	Direct_Rx	72189-613
Oxycodone HCL	Oxycodone hydrochloride 15 mg/1	TabletOral	Direct_Rx	72189-614
Oxycodone HCL	Oxycodone hydrochloride 5 mg/1	TabletOral	Direct_Rx	72189-618
Oxycodone HCL	Oxycodone hydrochloride 10 mg/1	TabletOral	Direct_Rx	72189-632
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-956
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Strides Pharma Science Limited	64380-259
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	Strides Pharma Science Limited	64380-260
Oxycodone Hydrochloride	Oxycodone hydrochloride 20 mg/1	TabletOral	Strides Pharma Science Limited	64380-262
Oxycodone Hydrochloride	Oxycodone hydrochloride 30 mg/1	TabletOral	Strides Pharma Science Limited	64380-263
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Redpharm Drug	67296-2188
Oxycodone Hydrochloride	Oxycodone hydrochloride 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-2816
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Asclemed USA, Inc.	76420-362
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	Asclemed USA, Inc.	76420-363
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	Asclemed USA, Inc.	76420-364
Oxycodone Hydrochloride	Oxycodone hydrochloride 20 mg/1	TabletOral	Asclemed USA, Inc.	76420-365
Oxycodone Hydrochloride	Oxycodone hydrochloride 30 mg/1	TabletOral	Asclemed USA, Inc.	76420-366