Prescription drug · ANDA
Meperidine Hydrochloride NDC 64950-214
Meperidine hydrochloride 50 mg/1 · Tablet · Oral · Genus Lifesciences Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64950-214-01 | 64950021401 | 100 TABLET in 1 BOTTLE, PLASTIC (64950-214-01)Marketed from Feb 14, 2024 | |
| 64950-214-03 | 64950021403 | 30 TABLET in 1 BOTTLE, PLASTIC (64950-214-03)Marketed from Feb 14, 2024 |
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)
- Meperidine Hydrochloride
- Generic name (nonproprietary)
- meperidine hydrochloride
- Active ingredients
- Meperidine hydrochloride — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Genus Lifesciences Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040893
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 64950-214_0f126de5-64f4-4a0d-8caa-e97acc3a2611SPL ID 0f126de5-64f4-4a0d-8caa-e97acc3a2611SPL set ID 792fefda-6cc4-4709-b902-fd9787fc310aRxCUI 861467UNII 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 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
N464950021401followed by a unit qualifier and the quantityPackage 64950-0214-01. 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)
Meperidine hydrochloride tablets 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 [see Warnings and Precautions (5.2) ], reserve opioid analgesics, including meperidine hydrochloride 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. Meperidine hydrochloride tablets should not be used for treatment of chronic…
Excerpt only. Read the full label for complete information.