Prescription drug · ANDA
Dexmedetomidine hydrochloride NDC 71872-7030
Dexmedetomidine hydrochloride 100 ug/mL · Injection, Solution · Intravenous · Medical Purchasing Solutions, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71872-7030-1 | 7187270300171872703001 | 1 VIAL in 1 BAG (71872-7030-1) / 2 mL in 1 VIALMarketed from Feb 28, 2020 |
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)
- Dexmedetomidine hydrochloride
- Generic name (nonproprietary)
- dexmedetomidine hydrochloride
- Active ingredients
- Dexmedetomidine hydrochloride — 100 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Medical Purchasing Solutions, LLCNDC labeler code 71872
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204023
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 71872-7030_fd163116-8854-9366-e053-6394a90a00b5SPL ID fd163116-8854-9366-e053-6394a90a00b5SPL set ID a2666c50-3b55-1380-e053-2a95a90aea58RxCUI 309710UNII 1018WH7F9IUPC 0371872703017
- 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.
- NDC on a medical claim
N471872703001followed by a unit qualifier and the quantityPackage 71872-7030-01. 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 .
Indications (excerpt from the label)
Dexmedetomidine hydrochloride injection is a relatively selective alpha 2 -adrenergic agonist indicated for: Sedation of non-intubated patients prior to and/or during surgical and other procedures. ( 1.2 ) 1.2 Procedural Sedation Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
Excerpt only. Read the full label for complete information.
About NDC 71872-7030
- What is NDC 71872-7030?
- 71872-7030 is the product NDC for Dexmedetomidine hydrochloride, Dexmedetomidine hydrochloride 100 ug/mL injection, solution, listed with the FDA by Medical Purchasing Solutions, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexmedetomidine hydrochloride.
- What is the active ingredient?
- Dexmedetomidine hydrochloride.
- Who is the labeler?
- Medical Purchasing Solutions, LLC, NDC labeler code 71872. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexmedetomidine hydrochloride?
- 38 other product NDCs are listed under this name. See all Dexmedetomidine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexmedetomidine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | Baxter Healthcare Corporation | 36000-262 | 36000-0262-0536000-0262-1036000-0262-25 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9198 | 00143-9198-10 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Sagent Pharmaceuticals | 25021-617 | 25021-0617-82 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Wilshire Pharmaceuticals, Inc. | 52536-125 | 52536-0125-10 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Wilshire Pharmaceuticals, Inc. | 52536-126 | 52536-0126-08 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Gland Pharma Limited | 68083-657 | 68083-0657-10 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-758 | 70069-0758-04 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-759 | 70069-0759-04 |
| Dexmedetomidine Hydrochloridedexmedetomidine hydrochloride in sodium chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1711 | 70121-1711-0270121-1711-09 |
| Dexmedetomidine Hydrochloridedexmedetomidine hydrochloride in sodium chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1712 | 70121-1712-0270121-1712-03 |
Other NDCs under ANDA 204023
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Accord Healthcare Inc. | 16729-239 |