NDC codes

FDA NDC Directory
Product NDC (as listed)0406-8515Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-8515Add 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
0406-8515-010040685150100406851501100 TABLET in 1 BOTTLE (0406-8515-01)Marketed from Jun 30, 2004
0406-8515-2300406851523004068515231 TABLET in 1 BLISTER PACK (0406-8515-23)Marketed from Jun 30, 2004
0406-8515-620040685156200406851562100 TABLET in 1 BLISTER PACK (0406-8515-62)Marketed from Jun 30, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
SpecGx LLCNDC labeler code 0406
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076758
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0406-8515_2b25e4bc-e02b-4fd0-a214-1da1b3fb5dd1SPL ID 2b25e4bc-e02b-4fd0-a214-1da1b3fb5dd1SPL set ID 928227bf-89c5-4c64-9823-0e84cc669388RxCUI 1049611, 1049618, 1049621, 1049683, 1049686UNII 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

N400406851501 followed by a unit qualifier and the quantity

Package 00406-8515-01. 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone hydrochloride tablets are an opioid agonist indicated for the management…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0406-8515

What is NDC 0406-8515?
0406-8515 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 15 mg/1 tablet, listed with the FDA by SpecGx LLC. 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?
SpecGx LLC, NDC labeler code 0406. 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 ANDA 076758

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

FDA NDC Directory listings under ANDA 076758
ProductStrengthForm · routeLabelerProduct NDC
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralSpecGx LLC0406-0552
Oxycodone HydrochlorideOxycodone hydrochloride 10 mg/1TabletOralSpecGx LLC0406-8510
Oxycodone HydrochlorideOxycodone hydrochloride 20 mg/1TabletOralSpecGx LLC0406-8520
Oxycodone HydrochlorideOxycodone hydrochloride 30 mg/1TabletOralSpecGx LLC0406-8530
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/1TabletOralRedpharm Drug67296-0425

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