Prescription drug · ANDA
Butorphanol Tartrate NDC 0143-9864
Butorphanol tartrate 1 mg/mL · Injection, Solution · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9864-10 | 00143986410 | 1 mL in 1 VIAL, SINGLE-DOSE (0143-9864-10)Marketed from May 1, 2009 |
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 — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078400
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0143-9864_b7be42f0-5b59-4a5a-a667-dfa81ff08b2aSPL ID b7be42f0-5b59-4a5a-a667-dfa81ff08b2aSPL set ID bded5531-8847-4576-9a29-3e44f979d2e0RxCUI 886627, 1728351UNII 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
N400143986410followed by a unit qualifier and the quantityPackage 00143-9864-10. 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, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Butorphanol Tartrate Injection for use in patients for whom alternative treatment options [e.g. non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated Have not provided adequate analgesia, or are not expected to pr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078400
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 2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9867 |