Prescription drug · ANDA
Midazolam NDC 0641-6211
Midazolam hydrochloride 5 mg/mL · Injection · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6211-10 | 00641621110 | 10 VIAL in 1 CARTON (0641-6211-10) / 10 mL in 1 VIAL (0641-6211-01)Marketed from Jun 20, 2000 |
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 075243
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0641-6211_6a9280fb-c775-443b-9f8e-1ed3a0c85d13SPL ID 6a9280fb-c775-443b-9f8e-1ed3a0c85d13SPL set ID 8675cdb1-c7f5-40cf-b1e0-0960b7ab117bRxCUI 311700, 311702UNII 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
N400641621110followed by a unit qualifier and the quantityPackage 00641-6211-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 075243
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. | 0641-6061 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6057 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-432 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-430 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6059 |
| Midazolam | Midazolam hydrochloride 5 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6190 |
| Midazolam | Midazolam hydrochloride 5 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6060 |
| Midazolam | Midazolam hydrochloride 5 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6063 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6281 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9913 |
| Midazolam | Midazolam hydrochloride 5 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9801 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6209 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6210 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9780 |
| Midazolam | Midazolam hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6056 |