NDC codes

FDA NDC Directory
Product NDC (as listed)60687-406Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0406Add 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
60687-406-67606870406675 TRAY in 1 CASE (60687-406-67) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-406-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-406-40)Marketed from Apr 22, 2019
60687-406-77606870406774 TRAY in 1 CASE (60687-406-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-406-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-406-40)Marketed from Apr 22, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 204037
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 60687-406_30ca5ab4-1e96-888b-e063-6294a90abae0SPL ID 30ca5ab4-1e96-888b-e063-6294a90abae0SPL set ID 0a6b0659-6816-4f44-81bd-9bac4da5380dRxCUI 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

N460687040667 followed by a unit qualifier and the quantity

Package 60687-0406-67. 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. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.2) ], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Oxycodone Hydrochloride Oral

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204037

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

FDA NDC Directory listings under ANDA 204037
ProductStrengthForm · routeLabelerProduct NDC
oxycodone hydrochlorideOxycodone hydrochloride 5 mg/5mLSolutionOralHikma Pharmceuticals USA Inc.0054-0390

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