Prescription drug · ANDA
Meperidine Hydrochloride NDC 0054-3545
Meperidine hydrochloride 50 mg/5mL · Solution · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-3545-63 | 00054354563 | 500 mL in 1 BOTTLE (0054-3545-63)Marketed from Jan 30, 1985 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Meperidine Hydrochloride
- Generic name (nonproprietary)
- meperidine hydrochloride
- Active ingredients
- Meperidine hydrochloride — 50 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088744
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0054-3545_677fb454-d83d-4c3c-b095-a58a1c4781b9SPL ID 677fb454-d83d-4c3c-b095-a58a1c4781b9SPL set ID 15bc51a8-1e24-4d33-9a2f-05a41c29acf0RxCUI 861455, 861467, 861479UNII N8E7F7Q170UPC 0300543545632
- 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
N400054354563followed by a unit qualifier and the quantityPackage 00054-3545-63. 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)
Meperidine Hydrochloride Tablets and Oral Solution are indicated for the management of acute 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, reserve opioid analgesics, including Meperidine Hydrochloride Tablets or 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. Use of Meperidine Hydrochloride Tablets or Oral Solution for an extended per…
Excerpt only. Read the full label for complete information.