Prescription drug · ANDA
Oxycodone Hydrochloride NDC 42858-002
Oxycodone hydrochloride 10 mg/1 · Tablet · Oral · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-002-01 | 4285800020142858000201 | 100 TABLET in 1 BOTTLE, PLASTIC (42858-002-01)Marketed from Sep 8, 2014 | |
| 42858-002-10 | 4285800021042858000210 | 10 BLISTER PACK in 1 CARTON (42858-002-10) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 8, 2014 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rhodes Pharmaceuticals LLCNDC labeler code 42858
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091490
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42858-002_d95a9c89-1435-4594-be8b-e19e23d07c0aSPL ID d95a9c89-1435-4594-be8b-e19e23d07c0aSPL set ID a5162476-1217-41c0-bc7e-0a0f123f069fRxCUI 1049611, 1049618, 1049621, 1049683, 1049686UNII C1ENJ2TE6CUPC 0342858002011, 0342858005012, 0342858004015, 0342858001014, 0342858003018
- 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
N442858000201followed by a unit qualifier and the quantityPackage 42858-0002-01. 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 Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) 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, reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerat…
Excerpt only. Read the full label for complete information.
About NDC 42858-002
- What is NDC 42858-002?
- 42858-002 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 10 mg/1 tablet, listed with the FDA by Rhodes Pharmaceuticals LLC. It has 2 package NDCs, 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?
- Rhodes Pharmaceuticals LLC, NDC labeler code 42858. 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?
- 131 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 20 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-486 | 31722-0486-0131722-0486-05 |
| 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 5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-954 | 60760-0954-3060760-0954-60 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-259 | 64380-0259-0164380-0259-02 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-262 | 64380-0262-01 |
| 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 091490
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 | Rhodes Pharmaceuticals LLC | 42858-001 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-003 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-004 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-005 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8526 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2899 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1413 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1414 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1421 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1422 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1334 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1335 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1336 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1337 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-757 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-758 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-761 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-762 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-897 |