Prescription drug · ANDA
Oxycodone And Acetaminophen NDC 10702-238
Oxycodone hydrochloride 5 mg/5mL; Acetaminophen 325 mg/5mL · Solution · Oral · KVK-Tech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-238-50 | 1070202385010702023850 | 500 mL in 1 BOTTLE (10702-238-50)Marketed from Dec 5, 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 And Acetaminophen
- Generic name (nonproprietary)
- oxycodone and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 5 mg/5mLAcetaminophen — 325 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- KVK-Tech, Inc.NDC labeler code 10702
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211499
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 10702-238_483734fe-f7da-e43c-e063-6294a90a8191SPL ID 483734fe-f7da-e43c-e063-6294a90a8191SPL set ID 9986aa04-c976-4654-8ad7-b97d2eecea93RxCUI 1049580UNII C1ENJ2TE6C, 362O9ITL9D
- 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
N410702023850followed by a unit qualifier and the quantityPackage 10702-0238-50. 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)
INDICATIONS AND USAGE Oxycodone Hydrochloride and Acetaminophen Oral Solution is indicated 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings ] , reserve opioid analgesics, including oxycodone hydrochloride and acetaminophen oral solution for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Excerpt only. Read the full label for complete information.
About NDC 10702-238
- What is NDC 10702-238?
- 10702-238 is the product NDC for Oxycodone And Acetaminophen, Oxycodone hydrochloride 5 mg/5mL; Acetaminophen 325 mg/5mL solution, listed with the FDA by KVK-Tech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone And Acetaminophen.
- What is the active ingredient?
- Oxycodone hydrochloride, Acetaminophen.
- Who is the labeler?
- KVK-Tech, Inc., NDC labeler code 10702. 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 And Acetaminophen?
- 110 other product NDCs are listed under this name. See all Oxycodone And Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxycodone And Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-898 | 60760-0898-3060760-0898-60 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-899 | 60760-0899-3060760-0899-6060760-0899-90 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-897 | 60760-0897-3060760-0897-60 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-368 | 72189-0368-3072189-0368-6072189-0368-72+1 more |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 60687-642 | 60687-0642-01 |
| Oxycodone and Acetaminophen | Acetaminophen 325 mg/1; Oxycodone hydrochloride 2.5 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-667 | 70010-0667-0170010-0667-05 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-668 | 70010-0668-0170010-0668-05 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-669 | 70010-0669-0170010-0669-05 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-670 | 70010-0670-0170010-0670-05 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | DIRECT RX | 72189-255 | 72189-0255-3072189-0255-60 |