Prescription drug · ANDA
Butorphanol Tartrate NDC 0409-1626
Butorphanol tartrate 2 mg/mL · Injection, Solution · Intramuscular, Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-1626-01 | 00409162601 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21)Marketed from Mar 17, 2006 | |
| 0409-1626-02 | 00409162602 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-1626-42)Marketed from Dec 20, 2005 |
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)
- Butorphanol Tartrate
- Generic name (nonproprietary)
- butorphanol tartrate
- Active ingredients
- Butorphanol tartrate — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074626
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0409-1626_280bcddf-00c7-4c78-a108-f86ce2d30f41SPL ID 280bcddf-00c7-4c78-a108-f86ce2d30f41SPL set ID 9822ca3f-aee2-46e5-8a96-495400e65d10RxCUI 886627, 1728351, 1728355UNII 2L7I72RUHN
- Pharmacologic class
- 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 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
N400409162601followed by a unit qualifier and the quantityPackage 00409-1626-01. 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 Butorphanol Tartrate Injection is indicated - as a preoperative or pre-anesthetic medication - as a supplement to balanced anesthesia - for the relief of pain during labor, and - 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 butorphanol tartrate, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074626
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 |
|---|---|---|---|---|
| Butorphanol Tartrate | Butorphanol tartrate 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hospira, Inc. | 0409-1623 |