Prescription drug · ANDA
Oxycodone Hydrochloride and Acetaminophen NDC 64850-623
Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Elite Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64850-623-01 | 6485006230164850062301 | 100 TABLET in 1 BOTTLE (64850-623-01)Marketed from Dec 4, 2017 | |
| 64850-623-05 | 6485006230564850062305 | 500 TABLET in 1 BOTTLE (64850-623-05)Marketed from Apr 9, 2026 |
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 and Acetaminophen
- Generic name (nonproprietary)
- oxycodone hydrochloride and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 10 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Elite Laboratories, Inc.NDC labeler code 64850
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209385
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 64850-623_523e66c8-fe6d-48c6-ab88-8c5eb25697b4SPL ID 523e66c8-fe6d-48c6-ab88-8c5eb25697b4SPL set ID 27fa8190-d334-4bb9-b277-d1f44db433e3RxCUI 1049214, 1049221, 1049225UNII 362O9ITL9D, C1ENJ2TE6CUPC 0364850621014, 0364850622011, 0364850623018
- 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
N464850062301followed by a unit qualifier and the quantityPackage 64850-0623-01. 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 & USAGE Oxycodone and acetaminophen 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 ], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options and ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Excerpt only. Read the full label for complete information.
About NDC 64850-623
- What is NDC 64850-623?
- 64850-623 is the product NDC for Oxycodone Hydrochloride and Acetaminophen, Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Elite Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone Hydrochloride and Acetaminophen.
- What is the active ingredient?
- Oxycodone hydrochloride, Acetaminophen.
- Who is the labeler?
- Elite Laboratories, Inc., NDC labeler code 64850. 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 and Acetaminophen?
- 6 other product NDCs are listed under this name. See all Oxycodone Hydrochloride and Acetaminophen 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 and Acetaminophen 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 and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-963 | 60760-0963-3060760-0963-60 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-964 | 60760-0964-3060760-0964-6060760-0964-90 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-965 | 60760-0965-3060760-0965-6060760-0965-90 |
| oxycodone hydrochloride and acetaminophen | Oxycodone hydrochloride 10 mg/5mL; Acetaminophen 300 mg/5mL | SolutionOral | FH2 Pharma LLC | 72887-648 | 72887-0648-12 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-621 | 64850-0621-0164850-0621-05 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-622 | 64850-0622-0164850-0622-05 |
Other NDCs under ANDA 209385
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 and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-963 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-964 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-965 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-621 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-622 |