Prescription drug · ANDA
oxycodone hydrochloride and acetaminophen NDC 72887-648
Oxycodone hydrochloride 10 mg/5mL; Acetaminophen 300 mg/5mL · Solution · Oral · FH2 Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72887-648-12 | 7288706481272887064812 | 120 mL in 1 BOTTLE, PLASTIC (72887-648-12)Marketed from Mar 1, 2020 |
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/5mLAcetaminophen — 300 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- FH2 Pharma LLCNDC labeler code 72887
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202142
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72887-648_507284c3-cad8-d65c-e063-6394a90a58a8SPL ID 507284c3-cad8-d65c-e063-6394a90a58a8SPL set ID 96b0067e-aabe-df4f-e053-2995a90a4a86RxCUI 2105822UNII C1ENJ2TE6C, 362O9ITL9DUPC 0372887648126
- 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
N472887064812followed by a unit qualifier and the quantityPackage 72887-0648-12. 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 hydrochloride and acetaminophen oral solution is 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 hydrochloride and acetaminophen oral solution, 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.
About NDC 72887-648
- What is NDC 72887-648?
- 72887-648 is the product NDC for oxycodone hydrochloride and acetaminophen, Oxycodone hydrochloride 10 mg/5mL; Acetaminophen 300 mg/5mL solution, listed with the FDA by FH2 Pharma LLC. It has 1 package NDC, 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?
- FH2 Pharma LLC, NDC labeler code 72887. 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 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 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-623 | 64850-0623-0164850-0623-05 |
Other NDCs under ANDA 202142
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 |
|---|---|---|---|---|
| Prolateoxycodone hydrochloride and acetaminophen | Oxycodone hydrochloride 10 mg/5mL; Acetaminophen 300 mg/5mL | SolutionOral | Forte Bio-Pharma LLC | 72245-648 |