Prescription drug · ANDA
Pentazocine Hydrochloride And Naloxone Hydrochloride NDC 43386-680
Pentazocine hydrochloride 50 mg/1; Naloxone hydrochloride .5 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-680-01 | 43386068001 | 100 TABLET in 1 BOTTLE (43386-680-01)Marketed from May 11, 2011 · Sample package |
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)
- Pentazocine Hydrochloride And Naloxone Hydrochloride
- Generic name (nonproprietary)
- pentazocine hydrochloride and naloxone hydrochloride
- Active ingredients
- Pentazocine hydrochloride — 50 mg/1Naloxone hydrochloride — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075735
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Competitive Opioid Antagonists (Mechanism)Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 43386-680_21e7776e-65d0-45fb-a1b2-13f49055ad64SPL ID 21e7776e-65d0-45fb-a1b2-13f49055ad64SPL set ID 017ef042-40aa-44c9-baa8-037f06356845RxCUI 312289UNII A36BXO4PPX, F850569PQRUPC 0343386680016
- Pharmacologic class
- Opioid Antagonist; Partial Opioid Agonist/Antagonist
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
N443386068001followed by a unit qualifier and the quantityPackage 43386-0680-01. 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 AND USAGE Pentazocine and Naloxone 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, reserve opioid analgesics, including Pentazocine and Naloxone 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.
Excerpt only. Read the full label for complete information.