What is NDC 13107-261?

13107-261 is the product NDC for Oxycodone Hydrochloride Oral Solution, Oxycodone hydrochloride 5 mg/5mL solution, listed with the FDA by Aurolife Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurolife Pharma, LLC, NDC labeler code 13107. 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 Oral Solution?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxycodone Hydrochloride Oral Solution NDC 13107-261

NDC codes

FDA NDC Directory

Product NDC (as listed)13107-261Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13107-0261Add 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 NDC	11-digit (billing)	Package	Copy
13107-261-58	13107026158	1 BOTTLE in 1 CARTON (13107-261-58) / 500 mL in 1 BOTTLEMarketed from Jan 27, 2020

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 Oral Solution
Generic name (nonproprietary): oxycodone hydrochloride oral solution
Active ingredients: Oxycodone hydrochloride — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Aurolife Pharma, LLCNDC labeler code 13107
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212429
Marketing start: Jan 27, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 13107-261_b0905edb-577e-4e2e-ab2f-c7f5c673b0e1SPL ID b0905edb-577e-4e2e-ab2f-c7f5c673b0e1SPL set ID 0b3fa92e-8351-4401-860d-4bba8a7155e6RxCUI 1049604, 1049615UNII C1ENJ2TE6CUPC 0313107262579, 0313107261589
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

N413107026158 followed by a unit qualifier and the quantity

Package 13107-0261-58. 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 Jan 18, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant patients. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [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 pr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13107-261

What is NDC 13107-261?: 13107-261 is the product NDC for Oxycodone Hydrochloride Oral Solution, Oxycodone hydrochloride 5 mg/5mL solution, listed with the FDA by Aurolife Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oxycodone Hydrochloride Oral Solution.
What is the active ingredient?: Oxycodone hydrochloride.
Who is the labeler?: Aurolife Pharma, LLC, NDC labeler code 13107. 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 Oral Solution?: 1 other product NDC are listed under this name. See all Oxycodone Hydrochloride Oral Solution 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 Oral Solution NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxycodone Hydrochloride Oral Solution	Oxycodone hydrochloride 100 mg/5mL	SolutionOral	Aurolife Pharma, LLC	13107-262	13107-0262-57

Other NDCs under ANDA 212429

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

FDA NDC Directory listings under ANDA 212429
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone Hydrochloride Oral Solution	Oxycodone hydrochloride 100 mg/5mL	SolutionOral	Aurolife Pharma, LLC	13107-262