NDC codes

FDA NDC Directory
Product NDC (as listed)0054-3090Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00054-3090Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0054-3090-36000543090361 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
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

N400054309036 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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