Prescription drug · ANDA
Midazolam NDC 0641-6219
Midazolam hydrochloride 5 mg/mL · Injection · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6219-10 | 00641621910 | 10 SYRINGE in 1 CARTON (0641-6219-10) / 2 mL in 1 SYRINGE (0641-6219-01)Marketed from Mar 29, 2024 |
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
- Active ingredients
- Midazolam hydrochloride — 5 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212847
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0641-6219_c7078d4a-0f37-4305-b20c-0a8f17382963SPL ID c7078d4a-0f37-4305-b20c-0a8f17382963SPL set ID 51c8bfa4-5c78-4b7a-9ffb-8f00828acadcRxCUI 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.
- NDC on a medical claim
N400641621910followed by a unit qualifier and the quantityPackage 00641-6219-10. 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)
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 relative…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212847
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 | Midazolam hydrochloride 5 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6218 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6220 |