Prescription drug · ANDA
Oxycodone and Acetaminophen NDC 42858-103
Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-103-01 | 42858010301 | 100 TABLET in 1 BOTTLE, PLASTIC (42858-103-01)Marketed from Aug 28, 2014 | |
| 42858-103-10 | 42858010310 | 10 BLISTER PACK in 1 CARTON (42858-103-10) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 28, 2014 | |
| 42858-103-50 | 42858010350 | 500 TABLET in 1 BOTTLE, PLASTIC (42858-103-50)Marketed from Aug 28, 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 and Acetaminophen
- Generic name (nonproprietary)
- oxycodone and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 7.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rhodes Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201278
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42858-103_5a4985b5-92c6-42a6-9279-25601ef4d009SPL ID 5a4985b5-92c6-42a6-9279-25601ef4d009SPL set ID 5999f3c3-3225-4d24-82cd-0b8d7a309587RxCUI 1049214, 1049221, 1049225UNII 362O9ITL9D, C1ENJ2TE6CUPC 0342858102018, 0342858103015, 0342858104012
- 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
N442858010301followed by a unit qualifier and the quantityPackage 42858-0103-01. 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)
INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets, USP 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 ], reserve opioid analgesics, including oxycodone and acetaminophen 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201278
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 |
|---|---|---|---|---|
| Percocetoxycodone/apap | Acetaminophen 325 mg/1; Oxycodone hydrochloride 10 mg/1 | TabletOral | Direct_Rx | 72189-397 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1420 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8876 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1472 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1492 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1909 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 63187-824 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-898 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-104 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-102 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9501 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-136 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | RedPharm Drug | 67296-1937 |
| Oxycodone/APAP | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-375 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-209 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1338 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1339 |