Prescription drug · ANDA
Oxycodone Hydrochloride NDC 68071-3600
Oxycodone hydrochloride 5 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3600-4 | 6807136000468071360004 | 4 TABLET in 1 BOTTLE (68071-3600-4)Marketed from May 8, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- 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 68071-3600_17f796b6-3f89-c988-e063-6394a90a7cb8SPL ID 17f796b6-3f89-c988-e063-6394a90a7cb8SPL set ID 17f7946d-e889-b736-e063-6394a90a42e0RxCUI 1049621UNII C1ENJ2TE6CUPC 0368071360042
- 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
N468071360004followed by a unit qualifier and the quantityPackage 68071-3600-04. 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 tablets are 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, even at recommended doses [see Warnings and Precautions ( 5.1 )] , reserve oxycodone hydrochloride tablets 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 tablets are an opioid agonist indicated fo…
Excerpt only. Read the full label for complete information.
About NDC 68071-3600
- What is NDC 68071-3600?
- 68071-3600 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 5 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone Hydrochloride.
- What is the active ingredient?
- Oxycodone hydrochloride.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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?
- 130 other product NDCs are listed under this name. See all Oxycodone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxycodone Hydrochloride 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 Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-967 | 60760-0967-3060760-0967-60 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-966 | 60760-0966-3060760-0966-60 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-484 | 31722-0484-0131722-0484-05 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-485 | 31722-0485-0131722-0485-05 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-486 | 31722-0486-0131722-0486-05 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-954 | 60760-0954-3060760-0954-60 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-956 | 60760-0956-3060760-0956-6060760-0956-90 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-259 | 64380-0259-0164380-0259-02 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-260 | 64380-0260-01 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-261 | 64380-0261-0164380-0261-02 |
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 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1245 |
| Oxycodone Hydchloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Quality Care Products LLC | 49999-899 |
| Oxycodone HCL | Oxycodone hydrochloride 5 mg/1 | TabletOral | Direct_Rx | 72189-611 |
| Oxycodone Hydchloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Quality Care Products LLC | 35356-839 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 68084-354 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | DIRECT RX | 72189-094 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | KVK-TECH,INC | 10702-018 |
| 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 30 mg/1 | TabletOral | KVK-TECH,INC | 10702-009 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 68084-968 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-954 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | American Health Packaging | 68084-975 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | American Health Packaging | 68084-983 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-957 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-955 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Quality Care Products LLC | 55700-174 |