Prescription drug · ANDA
Oxycodone and Acetaminophen NDC 10702-184
Oxycodone 2.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · KVK-Tech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-184-01 | 1070201840110702018401 | 100 TABLET in 1 BOTTLE (10702-184-01)Marketed from Feb 9, 2018 | |
| 10702-184-10 | 1070201841010702018410 | 1000 TABLET in 1 BOTTLE (10702-184-10)Marketed from Feb 9, 2018 | |
| 10702-184-50 | 1070201845010702018450 | 500 TABLET in 1 BOTTLE (10702-184-50)Marketed from Feb 9, 2018 |
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 — 2.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KVK-Tech, Inc.NDC labeler code 10702
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210644
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 10702-184_5104be8c-6b64-f19a-e063-6294a90ac130SPL ID 5104be8c-6b64-f19a-e063-6294a90ac130SPL set ID f9cf218c-af5e-4249-aa3b-a8555ed02278RxCUI 1049214, 1049221, 1049225, 1049635UNII 362O9ITL9D, CD35PMG570UPC 0310702185500, 0310702184107, 0310702187108, 0310702185104, 0310702186101, 0310702186507
- 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
N410702018401followed by a unit qualifier and the quantityPackage 10702-0184-01. 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 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, 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 10702-184
- What is NDC 10702-184?
- 10702-184 is the product NDC for Oxycodone and Acetaminophen, Oxycodone 2.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by KVK-Tech, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone and Acetaminophen.
- What is the active ingredient?
- Oxycodone, 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 |
Other NDCs under ANDA 210644
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 and Acetaminophen | Oxycodone 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-185 |
| Oxycodone and Acetaminophen | Oxycodone 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-186 |
| Oxycodone and Acetaminophen | Oxycodone 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-187 |