Prescription drug · ANDA
Midazolam (Midazolam hydrochloride) NDC 0409-2308
Midazolam hydrochloride 5 mg/mL · Injection, Solution · Intramuscular, Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-2308-49 | 0040923084900409230849 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-49) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2308-69)Marketed from Dec 28, 2005 | |
| 0409-2308-50 | 0040923085000409230850 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2308-50) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-2308-70)Marketed from Nov 21, 2005 |
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
- Generic name (nonproprietary)
- midazolam hydrochloride
- Active ingredients
- Midazolam hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075857
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0409-2308_2f69c5b1-6505-42dc-8bb3-edbd9b6c0781SPL ID 2f69c5b1-6505-42dc-8bb3-edbd9b6c0781SPL set ID b95415fa-17c2-42ab-a6b0-e628d01c94edRxCUI 1666800, 1666814, 1666823UNII 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
N400409230849followed by a unit qualifier and the quantityPackage 00409-2308-49. 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)
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 re…
Excerpt only. Read the full label for complete information.
About NDC 0409-2308
- What is NDC 0409-2308?
- 0409-2308 is the product NDC for Midazolam (midazolam hydrochloride), Midazolam hydrochloride 5 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Midazolam (Midazolam hydrochloride).
- What is the active ingredient?
- Midazolam hydrochloride.
- Who is the labeler?
- Hospira, Inc., NDC labeler code 0409. 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 075857
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 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hospira, Inc. | 0409-0001 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hospira, Inc. | 0409-2305 |
| Midazolammidazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-4743 |
| Midazolam Hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9916 |