NDC codes

FDA NDC Directory
Product NDC (as listed)0121-4827Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-4827Add 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
0121-4827-40001214827404 TRAY in 1 CASE (0121-4827-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4827-05)Marketed from Apr 10, 2019
0121-4827-50001214827505 TRAY in 1 CASE (0121-4827-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4827-05)Marketed from Jan 10, 2020

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 hydrochloride5 mg/5mL
Dosage form
Solution
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206914
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0121-4827_1685138a-dd0b-4e6e-b14d-a1132eef8b34SPL ID 1685138a-dd0b-4e6e-b14d-a1132eef8b34SPL set ID 73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1RxCUI 1049604UNII 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

N400121482740 followed by a unit qualifier and the quantity

Package 00121-4827-40. 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 is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid-analgesic and for which alternative treatments are inadequate. ( 1 ) L imitations 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, reserve opioid analgesics, including oxycodone hydrochloride or use in patients for whom alternative treatment options are ineffect

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206914

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

FDA NDC Directory listings under ANDA 206914
ProductStrengthForm · routeLabelerProduct NDC
Oxycodone HydrochlorideOxycodone hydrochloride 5 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-0827

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in