Prescription drug · ANDA
Dexmedetomidine Hydrochloride NDC 70121-1712
dexmedetomidine hydrochloride in sodium chloride · Dexmedetomidine hydrochloride 4 ug/mL · Injection · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1712-2 | 7012117120270121171202 | 10 POUCH in 1 CARTON (70121-1712-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Jan 8, 2024 | |
| 70121-1712-3 | 7012117120370121171203 | 12 POUCH in 1 CARTON (70121-1712-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from May 19, 2023 |
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 in sodium chloride
- Active ingredients
- Dexmedetomidine hydrochloride — 4 ug/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 70121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216604
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 70121-1712_06a08ff5-3a87-427a-9ecd-3a4300953037SPL ID 06a08ff5-3a87-427a-9ecd-3a4300953037SPL set ID 4df8cc35-fc80-4438-b982-9c4b7d17bad2RxCUI 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.
- NDC on a medical claim
N470121171202followed by a unit qualifier and the quantityPackage 70121-1712-02. 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 is a alpha 2 -adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult 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 adult 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 adult patients during treatment in an intensive care setting. Dexmedetomidine hydroc…
Excerpt only. Read the full label for complete information.
About NDC 70121-1712
- What is NDC 70121-1712?
- 70121-1712 is the product NDC for Dexmedetomidine Hydrochloride, Dexmedetomidine hydrochloride 4 ug/mL injection, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexmedetomidine Hydrochloride (Dexmedetomidine Hydrochloride in Sodium Chloride).
- What is the active ingredient?
- Dexmedetomidine hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 70121. 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 Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | CIVICA, INC. | 72572-127 | 72572-0127-10 |
Other NDCs under ANDA 216604
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 Hydrochloridedexmedetomidine hydrochloride in sodium chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1711 |