NDC codes

FDA NDC Directory
Product NDC (as listed)64950-354Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64950-0354Add 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
64950-354-1064950035410649500354101 BOTTLE, PLASTIC in 1 CARTON (64950-354-10) / 100 mL in 1 BOTTLE, PLASTICMarketed from Sep 9, 2013
64950-354-45649500354456495003544540 CUP, UNIT-DOSE in 1 CASE (64950-354-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)Marketed from Sep 9, 2013
64950-354-5064950035450649500354501 BOTTLE, PLASTIC in 1 CARTON (64950-354-50) / 500 mL in 1 BOTTLE, PLASTICMarketed from Sep 9, 2013
64950-354-55649500354556495003545550 CUP, UNIT-DOSE in 1 CASE (64950-354-55) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)Marketed from Sep 9, 2013

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/5mL
Dosage form
Solution
Route
Oral
Labeler
Genus Lifesciences Inc.NDC labeler code 64950
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 200535
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 64950-354_75ee6920-096a-4dd9-ae98-6991ab84daffSPL ID 75ee6920-096a-4dd9-ae98-6991ab84daffSPL set ID 6869fec9-1837-4221-afd8-5cc6fadd025dRxCUI 1049604, 1049615UNII C1ENJ2TE6CUPC 0364950353037, 0364950354058
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

N464950035410 followed by a unit qualifier and the quantity

Package 64950-0354-10. 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 Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2) ] , reserve opioid analgesi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64950-354

What is NDC 64950-354?
64950-354 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 5 mg/5mL solution, listed with the FDA by Genus Lifesciences Inc.. It has 4 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?
Genus Lifesciences Inc., NDC labeler code 64950. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-96760760-0967-3060760-0967-60
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-96660760-0966-3060760-0966-60
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralCamber Pharmaceuticals Inc31722-48431722-0484-0131722-0484-05
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralCamber Pharmaceuticals Inc31722-48531722-0485-0131722-0485-05
Oxycodone HydrochlorideOxycodone hydrochloride 20 mg/1TabletOralCamber Pharmaceuticals Inc31722-48631722-0486-0131722-0486-05
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-95460760-0954-3060760-0954-60
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-95660760-0956-3060760-0956-6060760-0956-90
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralStrides Pharma Science Limited64380-25964380-0259-0164380-0259-02
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralStrides Pharma Science Limited64380-26064380-0260-01
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralStrides Pharma Science Limited64380-26164380-0261-0164380-0261-02

All 131 Oxycodone Hydrochloride NDCs

Other NDCs under NDA 200535

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

FDA NDC Directory listings under NDA 200535
ProductStrengthForm · routeLabelerProduct NDC
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/5mLSolutionOralRedpharm Drug67296-2167

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