Prescription drug · ANDA
Oxycodone Hydrochloride NDC 68084-975
Oxycodone hydrochloride 15 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-975-01 | 68084097501 | 100 BLISTER PACK in 1 CARTON (68084-975-01) / 1 TABLET in 1 BLISTER PACK (68084-975-11)Marketed from Feb 25, 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
- Generic name (nonproprietary)
- oxycodone hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091393
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68084-975_4160b55c-48e1-5cb4-e063-6294a90a1d7dSPL ID 4160b55c-48e1-5cb4-e063-6294a90a1d7dSPL set ID aa7ac2bf-d9ed-445d-b394-4d3fe39780caRxCUI 1049611, 1049618, 1049621, 1049683UNII 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
N468084097501followed by a unit qualifier and the quantityPackage 68084-0975-01. 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)
Oxycodone hydrochloride 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, and misuse with opioids, which can occur at any dosage or duration even at recommended doses [see Warnings and Precautions (5.1) ] , reserve oxycodone hydrochloride 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 should not be used…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091393
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/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3600 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | DIRECT RX | 72189-094 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 68084-354 |
| Oxycodone Hydchloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Quality Care Products LLC | 49999-899 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | KVK-TECH,INC | 10702-056 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | KVK-TECH,INC | 10702-057 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | KVK-TECH,INC | 10702-008 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 68084-968 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | American Health Packaging | 68084-983 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | KVK-TECH,INC | 10702-009 |
| Oxycodone Hydchloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Quality Care Products LLC | 35356-839 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Quality Care Products LLC | 55700-174 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-954 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-955 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1245 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-957 |
| Oxycodone HCL | Oxycodone hydrochloride 5 mg/1 | TabletOral | Direct_Rx | 72189-611 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | KVK-TECH,INC | 10702-018 |