NDC codes

FDA NDC Directory
Product NDC (as listed)59011-960Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59011-0960Add 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
59011-960-105901109601010 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASSMarketed from Feb 8, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Nalmefene Hydrochloride
Generic name (nonproprietary)
nalmefene hydrochloride
Active ingredients
Nalmefene hydrochloride — 1 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous, Subcutaneous
Labeler
Knoa Pharma LLCNDC labeler code 59011
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212955
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 59011-960_5c39d4d2-5cb7-4840-b695-6b162e575301SPL ID 5c39d4d2-5cb7-4840-b695-6b162e575301SPL set ID 3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7RxCUI 2592953UNII K7K69QC05X
Pharmacologic class
Opioid 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

N459011096010 followed by a unit qualifier and the quantity

Package 59011-0960-10. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Nalmefene hydrochloride injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene hydrochloride injection is indicated in the management of known or suspected opioid overdose.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59011-960

What is NDC 59011-960?
59011-960 is the product NDC for Nalmefene Hydrochloride, Nalmefene hydrochloride 1 mg/mL injection, solution, listed with the FDA by Knoa Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nalmefene Hydrochloride.
What is the active ingredient?
Nalmefene hydrochloride.
Who is the labeler?
Knoa Pharma LLC, NDC labeler code 59011. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nalmefene Hydrochloride?
2 other product NDCs are listed under this name. See all Nalmefene Hydrochloride 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 Nalmefene Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
nalmefene hydrochloridenalmefene hydrochloride injectionNalmefene hydrochloride .1 mg/mLSolutionIntramuscular, Intravenous, SubcutaneousChengdu Shuode Pharmaceutical Co., Ltd82432-10182432-0101-01
nalmefene hydrochloridenalmefene hydrochloride injectionNalmefene hydrochloride 2 mg/2mLSolutionIntramuscular, Intravenous, SubcutaneousChengdu Shuode Pharmaceutical Co., Ltd82432-10282432-0102-02

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