Prescription drug · ANDA
Oxycodone Hydrochloride NDC 70752-137
Oxycodone hydrochloride 100 mg/5mL · Solution · Oral · QUAGEN PHARMACEUTICALS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70752-137-03 | 70752013703 | 1 BOTTLE in 1 CARTON (70752-137-03) / 30 mL in 1 BOTTLEMarketed from Jun 2, 2021 |
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 hydrochloride — 100 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- QUAGEN PHARMACEUTICALS LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213761
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 70752-137_16bbc411-6512-4799-a12d-12b7f3572afeSPL ID 16bbc411-6512-4799-a12d-12b7f3572afeSPL set ID 391701e5-2035-43fa-91ce-d27a1af19492RxCUI 1049604, 1049615UNII 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
N470752013703followed by a unit qualifier and the quantityPackage 70752-0137-03. 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 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, Ha…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213761
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/5mL | SolutionOral | QUAGEN PHARMACEUTICALS LLC | 70752-136 |