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NDC 63323-0412-02 Midazolam 5 mg/mL Details
Midazolam 5 mg/mL
Midazolam is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is MIDAZOLAM HYDROCHLORIDE.
MedlinePlus Drug Summary
Midazolam injection is used before medical procedures and surgery to cause drowsiness, relieve anxiety, and prevent any memory of the event. It is also sometimes given as part of the anesthesia during surgery to produce a loss of consciousness. Midazolam injection is also used to cause a state of decreased consciousness in seriously ill people in intensive care units (ICU) who are breathing with the help of a machine. Midazolam injection is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow relaxation and decreased consciousness.
Related Packages: 63323-0412-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Midazolam Injection
Product Information
| NDC | 63323-0412 |
|---|---|
| Product ID | 63323-412_87b0e4cc-f3b0-4d47-aaf2-f6748959095f |
| Associated GPIs | 60201025102010 60201025102025 60201025102050 60201025102005 |
| GCN Sequence Number | 070312 |
| GCN Sequence Number Description | midazolam HCl VIAL 10 MG/2 ML INJECTION |
| HIC3 | H22 |
| HIC3 Description | GENERAL ANESTHETICS,INJECTABLE-BENZODIAZEPINE TYPE |
| GCN | 33820 |
| HICL Sequence Number | 001619 |
| HICL Sequence Number Description | MIDAZOLAM HCL |
| Brand/Generic | Generic |
| Proprietary Name | Midazolam |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MIDAZOLAM HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | MIDAZOLAM HYDROCHLORIDE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA075154 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0412-02 (63323041202)
| NDC Package Code | 63323-412-02 |
|---|---|
| Billing NDC | 63323041202 |
| Package | 10 VIAL in 1 TRAY (63323-412-02) / 2 mL in 1 VIAL (63323-412-03) |
| Marketing Start Date | 2000-07-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |