NDC codes

FDA NDC Directory
Product NDC (as listed)0115-1560Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00115-1560Add 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
0115-1560-010011515600100115156001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1560-01)Marketed from Feb 22, 2016

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 — 40 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 022272
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0115-1560_335215a2-fcba-4158-bccb-79e026e05467SPL ID 335215a2-fcba-4158-bccb-79e026e05467SPL set ID c2c57ae7-86b9-47bb-a31b-ed1c4327ce7fRxCUI 1860127, 1860129, 1860137, 1860148, 1860151, 1860154, 1860157UNII C1ENJ2TE6CUPC 0301151561014
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

N400115156001 followed by a unit qualifier and the quantity

Package 00115-1560-01. 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 HCl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1) ] , reserve oxycodone HCl extended-relea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-1560

What is NDC 0115-1560?
0115-1560 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 40 mg/1 tablet, film coated, extended release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, 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?
Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 022272

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

FDA NDC Directory listings under NDA 022272
ProductStrengthForm · routeLabelerProduct NDC
OxyContinoxycodone hydrochlorideOxycodone hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralKnoa Pharma LLC59011-410
OxyContinoxycodone hydrochlorideOxycodone hydrochloride 15 mg/1Tablet, Film coated, Extended releaseOralKnoa Pharma LLC59011-415
OxyContinoxycodone hydrochlorideOxycodone hydrochloride 20 mg/1Tablet, Film coated, Extended releaseOralKnoa Pharma LLC59011-420
OxyContinoxycodone hydrochlorideOxycodone hydrochloride 30 mg/1Tablet, Film coated, Extended releaseOralKnoa Pharma LLC59011-430
OxyContinoxycodone hydrochlorideOxycodone hydrochloride 40 mg/1Tablet, Film coated, Extended releaseOralKnoa Pharma LLC59011-440
OxyContinoxycodone hydrochlorideOxycodone hydrochloride 60 mg/1Tablet, Film coated, Extended releaseOralKnoa Pharma LLC59011-460
OxyContinoxycodone hydrochlorideOxycodone hydrochloride 80 mg/1Tablet, Film coated, Extended releaseOralKnoa Pharma LLC59011-480

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