Prescription drug · ANDA
Midazolam in Sodium Chloride NDC 0143-9380
Midazolam hydrochloride 1 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9380-10 | 0014393801000143938010 | 10 POUCH in 1 CARTON (0143-9380-10) / 1 BAG in 1 POUCH (0143-9380-01) / 100 mL in 1 BAGMarketed from May 19, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216159
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0143-9380_a6be32fe-dc3d-4ce0-b780-8ba6b4261accSPL ID a6be32fe-dc3d-4ce0-b780-8ba6b4261accSPL set ID 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1RxCUI 2541170, 2541171UNII W7TTW573JJ
- 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
N400143938010followed by a unit qualifier and the quantityPackage 00143-9380-10. 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 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 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.
About NDC 0143-9380
- What is NDC 0143-9380?
- 0143-9380 is the product NDC for Midazolam in Sodium Chloride, Midazolam hydrochloride 1 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Midazolam in Sodium Chloride.
- What is the active ingredient?
- Midazolam hydrochloride.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Midazolam in Sodium Chloride?
- 7 other product NDCs are listed under this name. See all Midazolam in Sodium Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Midazolam in Sodium Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Midazolam in Sodium Chloridemidazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-688 | 25021-0688-8225021-0688-87 |
| Midazolam In Sodium Chloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntravenous | FRESENIUS KABI USA, LLC | 65219-650 | 65219-0650-1065219-0650-50 |
| Midazolam In Sodium Chloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-618 | 68083-0618-10 |
| Midazolam In Sodium Chloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-619 | 68083-0619-10 |
| Midazolam in Sodium Chloride | Midazolam hydrochloride 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9379 | 00143-9379-10 |
| Midazolam in Sodium Chloridemidazolam | Midazolam 1 mg/mL | Injection, SolutionIntravenous | WG Critical Care, LLC. | 44567-610 | 44567-0610-10 |
| Midazolam in Sodium Chloridemidazolam | Midazolam 1 mg/mL | Injection, SolutionIntravenous | WG Critical Care, LLC. | 44567-611 | 44567-0611-10 |
Other NDCs under ANDA 216159
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 Chloride | Midazolam hydrochloride 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9379 |