NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1418Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1418Add 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
51662-1418-151662141801516621418011 VIAL, MULTI-DOSE in 1 CARTON (51662-1418-1) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 29, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Nalbuphine Hci
Generic name (nonproprietary)
nalbuphine hci
Active ingredients
Nalbuphine hydrochloride — 20 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous, Subcutaneous
Labeler
HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 070918
Marketing start
Listing expires
Other FDA classes
Competitive Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 51662-1418_2b37c24d-1ab8-34d6-e063-6294a90abf70SPL ID 2b37c24d-1ab8-34d6-e063-6294a90abf70SPL set ID 96128b54-24d6-88a3-e053-2a95a90a1c9cRxCUI 904440UNII ZU4275277R
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

N451662141801 followed by a unit qualifier and the quantity

Package 51662-1418-01. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Nalbuphine Hydrochloride 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1418

What is NDC 51662-1418?
51662-1418 is the product NDC for Nalbuphine Hci, Nalbuphine hydrochloride 20 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nalbuphine Hci.
What is the active ingredient?
Nalbuphine hydrochloride.
Who is the labeler?
HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nalbuphine Hci?
1 other product NDC are listed under this name. See all Nalbuphine Hci 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 Nalbuphine Hci NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nalbuphine HciNalbuphine hydrochloride 10 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-142051662-1420-01

Other NDCs under ANDA 070918

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

FDA NDC Directory listings under ANDA 070918
ProductStrengthForm · routeLabelerProduct NDC
Nalbuphine HydrochlorideNalbuphine hydrochloride 20 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousHospira, Inc.0409-1467
Nalbuphine HydrochlorideNalbuphine hydrochloride 20 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousMedical Purchasing Solutions, LLC71872-7320

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