Prescription drug · ANDA
Midazolam In 0.8% Sodium Chloride NDC 0264-8005
Midazolam 1 mg/mL · Injection, Solution · Intravenous · B. Braun Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0264-8005-31 | 0026480053100264800531 | 40 CONTAINER in 1 CASE (0264-8005-31) / 50 mL in 1 CONTAINERMarketed from Oct 15, 2025 |
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 0.8% Sodium Chloride
- Generic name (nonproprietary)
- midazolam in 0.8% sodium chloride
- Active ingredients
- Midazolam — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- B. Braun Medical Inc.NDC labeler code 0264
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218454
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0264-8005_1287da80-6b0a-4ba3-b698-d1dc0e78c294SPL ID 1287da80-6b0a-4ba3-b698-d1dc0e78c294SPL set ID adfe8ece-496d-4118-9990-a1d44d0ac7d9RxCUI 2541170, 2541171UNII R60L0SM5BC
- 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
N400264800531followed by a unit qualifier and the quantityPackage 00264-8005-31. 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.
Excerpt only. Read the full label for complete information.
About NDC 0264-8005
- What is NDC 0264-8005?
- 0264-8005 is the product NDC for Midazolam In 0.8% Sodium Chloride, Midazolam 1 mg/mL injection, solution, listed with the FDA by B. Braun Medical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Midazolam In 0.8% Sodium Chloride.
- What is the active ingredient?
- Midazolam.
- Who is the labeler?
- B. Braun Medical Inc., NDC labeler code 0264. 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 0.8% Sodium Chloride?
- 1 other product NDC are listed under this name. See all Midazolam In 0.8% 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 0.8% 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 0.8% Sodium Chloride | Midazolam 1 mg/mL | Injection, SolutionIntravenous | B. Braun Medical Inc. | 0264-8002 | 00264-8002-32 |
Other NDCs under ANDA 218454
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 0.8% Sodium Chloride | Midazolam 1 mg/mL | Injection, SolutionIntravenous | B. Braun Medical Inc. | 0264-8002 |