Prescription drug · ANDA
Midazolam In Sodium Chloride NDC 68083-618
Midazolam hydrochloride 1 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-618-10 | 68083061810 | 10 POUCH in 1 CARTON (68083-618-10) / 1 BAG in 1 POUCH / 50 mL in 1 BAGMarketed from Aug 12, 2024 |
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)
- Midazolam In Sodium Chloride
- Generic name (nonproprietary)
- midazolam in sodium chloride
- Active ingredients
- Midazolam hydrochloride — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218993
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 68083-618_fda891ec-dee1-4978-a550-8c10c1cf3d8cSPL ID fda891ec-dee1-4978-a550-8c10c1cf3d8cSPL set ID 9ba78a7c-5b05-42a3-89cd-ca51ad9b2e6dRxCUI 2541170, 2541171UNII W7TTW573JJUPC 0368083619015, 0368083618018
- Pharmacologic class
- Benzodiazepine
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
N468083061810followed by a unit qualifier and the quantityPackage 68083-0618-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Midazolam in 0.9% Sodium Chloride Injection is indicated: • Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. Midazolam in 0.9% Sodium Chloride Injection is a benzodiazepine indicated for: continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218993
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 |
|---|---|---|---|---|
| Midazolam in Sodium Chloridemidazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-688 |
| Midazolam In Sodium Chloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-650 |
| Midazolam In Sodium Chloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-619 |