Prescription drug · ANDA
Oxycodone Hydrochloride NDC 71335-2126
Oxycodone hydrochloride 30 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2126-1 | 71335212601 | 60 TABLET in 1 BOTTLE (71335-2126-1)Marketed from Jul 18, 2022 | |
| 71335-2126-2 | 71335212602 | 90 TABLET in 1 BOTTLE (71335-2126-2)Marketed from Jul 18, 2022 | |
| 71335-2126-3 | 71335212603 | 120 TABLET in 1 BOTTLE (71335-2126-3)Marketed from Jul 18, 2022 | |
| 71335-2126-4 | 71335212604 | 30 TABLET in 1 BOTTLE (71335-2126-4)Marketed from Jul 18, 2022 | |
| 71335-2126-5 | 71335212605 | 100 TABLET in 1 BOTTLE (71335-2126-5)Marketed from Jul 18, 2022 | |
| 71335-2126-6 | 71335212606 | 40 TABLET in 1 BOTTLE (71335-2126-6)Marketed from Jul 18, 2022 | |
| 71335-2126-7 | 71335212607 | 18 TABLET in 1 BOTTLE (71335-2126-7)Marketed from Jul 18, 2022 | |
| 71335-2126-8 | 71335212608 | 28 TABLET in 1 BOTTLE (71335-2126-8)Marketed from Jul 18, 2022 |
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 — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207418
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 71335-2126_fb79d3c2-1784-4970-abea-e1ab02a16c58SPL ID fb79d3c2-1784-4970-abea-e1ab02a16c58SPL set ID 27124cdf-a3e8-474c-9c1e-6fa48f6ddc05RxCUI 1049618UNII 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
N471335212601followed by a unit qualifier and the quantityPackage 71335-2126-01. 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, 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 is an opioid agonist indicated for the m…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207418
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 10 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-485 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-484 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-486 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8890 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-917 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-918 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc | 72865-129 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc | 72865-128 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1930 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-966 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-967 |