Prescription drug · ANDA
Meperidine Hydrochloride NDC 0641-6053
Meperidine hydrochloride 50 mg/mL · Injection · Intramuscular, Intravenous, Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6053-25 | 00641605325 | 25 VIAL in 1 CARTON (0641-6053-25) / 1 mL in 1 VIAL (0641-6053-01)Marketed from Jan 22, 1975 |
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/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080445
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0641-6053_9566d54d-7343-4695-94ff-8b5f2d384c81SPL ID 9566d54d-7343-4695-94ff-8b5f2d384c81SPL set ID e0e998da-f056-4fce-be8e-ed60cf3b461bRxCUI 861476, 1665685, 1665697UNII N8E7F7Q170
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400641605325followed by a unit qualifier and the quantityPackage 00641-6053-25. 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 Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. Meperidine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, for obstetrical analgesia, and for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 080445
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 |
|---|---|---|---|---|
| Meperidine Hydrochloride | Meperidine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6052 |
| Meperidine Hydrochloride | Meperidine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6054 |