Prescription drug · ANDA
Midazolam (Midazolam hydrochloride) NDC 76045-003
Midazolam hydrochloride 10 mg/2mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Midazolam
- Generic name (nonproprietary)
- midazolam hydrochloride
- Active ingredients
- Midazolam hydrochloride — 10 mg/2mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 76045
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203460
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 76045-003_ec9c9aee-b95f-4645-bf17-df7f1e3967d3SPL ID ec9c9aee-b95f-4645-bf17-df7f1e3967d3SPL set ID 1cc9ba6e-fa1b-405e-9de8-720c567b2a73RxCUI 998211, 1551393, 1551395UNII 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE: Midazolam injection is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relativ…
Excerpt only. Read the full label for complete information.
About NDC 76045-003
- What is NDC 76045-003?
- 76045-003 is the product NDC for Midazolam (midazolam hydrochloride), Midazolam hydrochloride 10 mg/2mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC.
- What drug is associated with this NDC?
- Midazolam (Midazolam Hydrochloride).
- What is the active ingredient?
- Midazolam hydrochloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 76045. 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?
- 49 other product NDCs are listed under this name. See all Midazolam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Midazolam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Onesource Specialty Pharma Limited | 83270-170 | 83270-0170-10 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Onesource Specialty Pharma Limited | 83270-171 | 83270-0171-10 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Onesource Specialty Pharma Limited | 83270-172 | 83270-0172-10 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Onesource Specialty Pharma Limited | 83270-173 | 83270-0173-10 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Onesource Specialty Pharma Limited | 83270-174 | 83270-0174-10 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Onesource Specialty Pharma Limited | 83270-175 | 83270-0175-10 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Onesource Specialty Pharma Limited | 83270-176 | 83270-0176-10 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9780 | 00404-9780-10 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 2 mg/2mL | Injection, SolutionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4328 | 70518-4328-00 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hospira, Inc. | 0409-0001 | 00409-0001-25 |
Other NDCs under ANDA 203460
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 |
|---|---|---|---|---|
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 2 mg/2mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 76045-001 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 76045-002 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 2 mg/2mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 76045-211 |