Prescription drug · ANDA
Butorphanol Tartrate NDC 72162-2099
Butorphanol tartrate 10 mg/mL · Spray · Nasal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2099-2 | 72162209902 | 1 BOTTLE, SPRAY in 1 CONTAINER (72162-2099-2) / 2.5 mL in 1 BOTTLE, SPRAYMarketed from Sep 19, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075499
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72162-2099_2ed74d4d-331d-4663-9dfd-1e87ea1a3a78SPL ID 2ed74d4d-331d-4663-9dfd-1e87ea1a3a78SPL set ID 412499ce-db93-4943-ae1a-564c27b1fb16RxCUI 886634UNII 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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472162209902followed by a unit qualifier and the quantityPackage 72162-2099-02. 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 nasal spray is 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, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS ] reserve butorphanol tartrate nasal spray 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 provide adequate analgesia Butorphanol tartrate nasal spray should not be used for an extended period of t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075499
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 10 mg/mL | SprayNasal | Apotex Corp. | 60505-0813 |