NDC codes

FDA NDC Directory
Product NDC (as listed)0409-1626Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-1626Add 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
0409-1626-01004091626010040916260110 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21)Marketed from Mar 17, 2006
0409-1626-02004091626020040916260210 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.NDC labeler code 0409
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_f9eb40ee-3daa-423d-ac1f-be76b7f267e2SPL ID f9eb40ee-3daa-423d-ac1f-be76b7f267e2
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.

How CPT relates to drug billing

NDC on a medical claim

N400409162601 followed by a unit qualifier and the quantity

Package 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0409-1626

What is NDC 0409-1626?
0409-1626 is the product NDC for Butorphanol Tartrate, Butorphanol tartrate 2 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 2 package NDCs, 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?
Hospira, Inc., NDC labeler code 0409. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Butorphanol Tartrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Butorphanol TartrateButorphanol tartrate 1 mg/mLInjection, SolutionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0143-986400143-9864-10
Butorphanol TartrateButorphanol tartrate 2 mg/mLInjection, SolutionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0143-986700143-9867-10
Butorphanol TartrateButorphanol tartrate 1 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-162300409-1623-01
Butorphanol TartrateButorphanol tartrate 10 mg/mLSprayNasalApotex Corp.60505-081360505-0813-01
Butorphanol TartrateButorphanol tartrate 10 mg/mLSprayNasalBryant Ranch Prepack72162-209972162-2099-02
Butorphanol TartrateButorphanol tartrate 10 mg/mLSpray, MeteredNasalHikma Pharmaceuticals USA Inc.0054-309000054-3090-36

Other NDCs under ANDA 074626

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074626
ProductStrengthForm · routeLabelerProduct NDC
Butorphanol TartrateButorphanol tartrate 1 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-1623

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