Prescription drug · ANDA
Oxycodone Hydchloride NDC 35356-839
Oxycodone hydrochloride 10 mg/1 · Tablet · Oral · Quality Care Products LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35356-839-30 | 3535608393035356083930 | 30 TABLET in 1 BOTTLE (35356-839-30)Marketed from Dec 20, 2011 | |
| 35356-839-60 | 3535608396035356083960 | 60 TABLET in 1 BOTTLE (35356-839-60)Marketed from Apr 30, 2021 | |
| 35356-839-90 | 3535608399035356083990 | 90 TABLET in 1 BOTTLE (35356-839-90)Marketed from Dec 20, 2011 |
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 Hydchloride
- Generic name (nonproprietary)
- oxycodone hydchloride
- Active ingredients
- Oxycodone hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Quality Care Products LLCNDC labeler code 35356
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091393
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 35356-839_d1220dd0-8ab8-47f6-9da9-e22ea724cda0SPL ID d1220dd0-8ab8-47f6-9da9-e22ea724cda0SPL set ID 28156b13-0ba9-4dc4-be24-9c3070a7e1ccRxCUI 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
N435356083930followed by a unit qualifier and the quantityPackage 35356-0839-30. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
Excerpt only. Read the full label for complete information.
About NDC 35356-839
- What is NDC 35356-839?
- 35356-839 is the product NDC for Oxycodone Hydchloride, Oxycodone hydrochloride 10 mg/1 tablet, listed with the FDA by Quality Care Products LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone Hydchloride.
- What is the active ingredient?
- Oxycodone hydrochloride.
- Who is the labeler?
- Quality Care Products LLC, NDC labeler code 35356. 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 Hydchloride?
- 1 other product NDC are listed under this name. See all Oxycodone Hydchloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxycodone Hydchloride 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 Hydchloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Quality Care Products LLC | 49999-899 | 49999-0899-1549999-0899-3049999-0899-60 |
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 Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3600 |
| 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 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 |