Prescription drug · ANDA
Oxycodone hydrochloride NDC 47781-263
Oxycodone hydrochloride 5 mg/1 · Tablet · Oral · Alvogen, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-263-01 | 4778102630147781026301 | 100 TABLET in 1 BOTTLE (47781-263-01)Marketed from Dec 30, 2011 | |
| 47781-263-05 | 4778102630547781026305 | 500 TABLET in 1 BOTTLE (47781-263-05)Marketed from Dec 30, 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 hydrochloride
- Generic name (nonproprietary)
- oxycodone hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Alvogen, Inc.NDC labeler code 47781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202116
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 47781-263_aa023689-6275-e0a0-ab08-d45edc45ec40SPL ID aa023689-6275-e0a0-ab08-d45edc45ec40SPL set ID 20bb6bb4-230a-c9c2-01d8-a6e9341e96baRxCUI 1049611, 1049618, 1049621UNII C1ENJ2TE6CUPC 0347781264017, 0347781263010, 0347781265014
- 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
N447781026301followed by a unit qualifier and the quantityPackage 47781-0263-01. 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 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone hydrochloride tablets are an opioid agonist indicated for the management…
Excerpt only. Read the full label for complete information.
About NDC 47781-263
- What is NDC 47781-263?
- 47781-263 is the product NDC for Oxycodone hydrochloride, Oxycodone hydrochloride 5 mg/1 tablet, listed with the FDA by Alvogen, Inc.. 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?
- Alvogen, Inc., NDC labeler code 47781. 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 202116
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 15 mg/1 | TabletOral | Alvogen, Inc. | 47781-264 |
| Oxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Alvogen, Inc. | 47781-265 |
| Oxycodone hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-763 |
| Oxycodone hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-764 |
| Oxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-768 |