Dexmedetomidine Hydrochloride NDC 43598-976

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-976Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0976Add 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 NDC	11-digit (billing)	Package	Copy
43598-976-58	43598097658	10 VIAL in 1 CARTON (43598-976-58) / 50 mL in 1 VIAL (43598-976-11)Marketed from Aug 17, 2020

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): Dexmedetomidine Hydrochloride
Generic name (nonproprietary): dexmedetomidine hydrochloride
Active ingredients: Dexmedetomidine hydrochloride — 4 ug/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Dr.Reddy's Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209307
Marketing start: Aug 17, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 43598-976_5785a11f-7784-4ae0-8029-f50b782eaf4aSPL ID 5785a11f-7784-4ae0-8029-f50b782eaf4aSPL set ID d174c19d-56f1-4ef4-087c-23c26db8e40bRxCUI 1718906, 1718909UNII 1018WH7F9I
Pharmacologic class: Central alpha-2 Adrenergic Agonist

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

N443598097658 followed by a unit qualifier and the quantity

Package 43598-0976-58. 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 Jul 1, 2022.

Indications (excerpt from the label)

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha 2 -adrenergic agonist indicated for: Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. ( 1.1 ). Sedation of non-intubated patients prior to and/or during surgical and other procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care se…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209307

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

FDA NDC Directory listings under ANDA 209307
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Gland Pharma Limited	68083-238
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Gland Pharma Limited	68083-239
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	Injection, SolutionIntravenous	Dr.Reddy's Laboratories Inc	43598-975
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Sagent Pharmaceuticals	25021-617
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Piramal Critical Care Inc	66794-234
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Piramal Critical Care Inc	66794-235
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Gland Pharma Limited	68083-657