Prescription drug · ANDA
Butorphanol Tartrate NDC 0054-3090
Butorphanol tartrate 10 mg/mL · Spray, Metered · Nasal · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-3090-36 | 0005430903600054309036 | 1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36) / 2.5 mL in 1 BOTTLE, SPRAYMarketed from Mar 12, 2002 |
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 — 10 mg/mL
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075824
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0054-3090_57de4cd2-a163-4ac7-9e86-a04355a00d78SPL ID 57de4cd2-a163-4ac7-9e86-a04355a00d78SPL set ID 5a50d22e-acbe-4b15-9ed6-70713378408aRxCUI 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
N400054309036followed by a unit qualifier and the quantityPackage 00054-3090-36. 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, 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 Nasal Spray, 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.
About NDC 0054-3090
- What is NDC 0054-3090?
- 0054-3090 is the product NDC for Butorphanol Tartrate, Butorphanol tartrate 10 mg/mL spray, metered, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butorphanol Tartrate.
- What is the active ingredient?
- Butorphanol tartrate.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Butorphanol Tartrate?
- 6 other product NDCs are listed under this name. See all Butorphanol Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Butorphanol Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Butorphanol Tartrate | Butorphanol tartrate 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9864 | 00143-9864-10 |
| Butorphanol Tartrate | Butorphanol tartrate 2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9867 | 00143-9867-10 |
| Butorphanol Tartrate | Butorphanol tartrate 2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hospira, Inc. | 0409-1626 | 00409-1626-0100409-1626-02 |
| Butorphanol Tartrate | Butorphanol tartrate 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hospira, Inc. | 0409-1623 | 00409-1623-01 |
| Butorphanol Tartrate | Butorphanol tartrate 10 mg/mL | SprayNasal | Apotex Corp. | 60505-0813 | 60505-0813-01 |
| Butorphanol Tartrate | Butorphanol tartrate 10 mg/mL | SprayNasal | Bryant Ranch Prepack | 72162-2099 | 72162-2099-02 |