NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9864Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9864Add 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
0143-9864-1000143986410001439864101 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
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
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.

How CPT relates to drug billing

NDC on a medical claim

N400143986410 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9864

What is NDC 0143-9864?
0143-9864 is the product NDC for Butorphanol Tartrate, Butorphanol tartrate 1 mg/mL injection, solution, 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 0143. 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 2 mg/mLInjection, SolutionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0143-986700143-9867-10
Butorphanol TartrateButorphanol tartrate 2 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-162600409-1626-0100409-1626-02
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 078400

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

FDA NDC Directory listings under ANDA 078400
ProductStrengthForm · routeLabelerProduct NDC
Butorphanol TartrateButorphanol tartrate 2 mg/mLInjection, SolutionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0143-9867

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