Prescription drug · ANDA

Oxymorphone hydrochloride NDC 0115-1233

Oxymorphone hydrochloride 20 mg/1 · Tablet, Film coated, Extended release · Oral · Amneal Pharmaceuticals of New York LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0115-1233Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00115-1233Add 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
0115-1233-0100115123301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-01)Marketed from Jan 2, 2013
0115-1233-03001151233031000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-03)Marketed from Jan 2, 2013
0115-1233-080011512330830 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-08)Marketed from Jan 2, 2013
0115-1233-130011512331360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1233-13)Marketed from Jan 2, 2013

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)
Oxymorphone hydrochloride
Generic name (nonproprietary)
oxymorphone hydrochloride
Active ingredients
Oxymorphone hydrochloride — 20 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079087
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0115-1233_a8dc6624-df1e-4e5a-b445-9541658e3430SPL ID a8dc6624-df1e-4e5a-b445-9541658e3430SPL set ID 557e9610-62d7-42bf-90c1-44215bd8c1f8RxCUI 977874, 977894, 977902, 977909, 977915, 977923, 977929UNII 5Y2EI94NBC
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

N400115123301 followed by a unit qualifier and the quantity

Package 00115-1233-01. 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)

Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-r…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079087

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

FDA NDC Directory listings under ANDA 079087
ProductStrengthForm · routeLabelerProduct NDC
Oxymorphone hydrochlorideOxymorphone hydrochloride 20 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-699
Oxymorphone hydrochlorideOxymorphone hydrochloride 7.5 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-696
Oxymorphone hydrochlorideOxymorphone hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-697
Oxymorphone hydrochlorideOxymorphone hydrochloride 15 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-698
Oxymorphone hydrochlorideOxymorphone hydrochloride 30 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-700
Oxymorphone hydrochlorideOxymorphone hydrochloride 40 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-701
Oxymorphone hydrochlorideOxymorphone hydrochloride 7.5 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1315
Oxymorphone hydrochlorideOxymorphone hydrochloride 15 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1316
Oxymorphone hydrochlorideOxymorphone hydrochloride 30 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1317
Oxymorphone hydrochlorideOxymorphone hydrochloride 5 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals LLC64896-695
Oxymorphone hydrochlorideOxymorphone hydrochloride 5 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1231
Oxymorphone hydrochlorideOxymorphone hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1232
Oxymorphone hydrochlorideOxymorphone hydrochloride 40 mg/1Tablet, Film coated, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1234

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