NDC codes

FDA NDC Directory
Product NDC (as listed)0115-1315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00115-1315Add 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
0115-1315-0100115131501100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-01)Marketed from Jan 2, 2013
0115-1315-03001151315031000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-03)Marketed from Jan 2, 2013
0115-1315-080011513150830 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-08)Marketed from Jan 2, 2013
0115-1315-130011513151360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-13)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 — 7.5 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 0115-1315_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

N400115131501 followed by a unit qualifier and the quantity

Package 00115-1315-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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