NDC 63323-411

Midazolam

Midazolam Hydrochloride

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.

• Product ID: 63323-411_8ef4c263-4fb6-4155-899c-bfed5b16cf59
• NDC: 63323-411
• Product Type: Human Prescription Drug
• Proprietary Name: Midazolam
• Generic Name: Midazolam Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2000-07-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075154
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: MIDAZOLAM HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63323-411-10

10 VIAL in 1 TRAY (63323-411-10) > 10 mL in 1 VIAL (63323-411-13)

• Marketing Start Date: 2000-07-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-411-15 [63323041115]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075154
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-12-22

NDC 63323-411-12 [63323041112]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075154
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-07-14

NDC 63323-411-10 [63323041110]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075154
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-07-14

NDC 63323-411-18 [63323041118]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075154
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-12-22

NDC 63323-411-13 [63323041113]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075154
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-12-22

NDC 63323-411-25 [63323041125]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075154
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-07-14

Drug Details

Active Ingredients

Ingredient	Strength
MIDAZOLAM HYDROCHLORIDE	1 mg/mL

OpenFDA Data

• SPL SET ID: a91ce254-14a3-4cbf-8ab8-5da252aa3fdc
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • W7TTW573JJ
• RxNorm Concept Unique ID - RxCUI:
  • 311702
  • 311700

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]

Medicade Reported Pricing

63323041112 MIDAZOLAM HCL 2 MG/2 ML VIAL

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Midazolam" or generic name "Midazolam Hydrochloride"

NDC	Brand Name	Generic Name
0404-9912	Midazolam	Midazolam
0404-9913	Midazolam	Midazolam
0404-9914	MIDAZOLAM	midazoalm
0404-9915	Midazolam	Midazolam
70860-601	Midazolam	Midazolam
70860-600	Midazolam	Midazolam
76045-003	Midazolam	Midazolam
76045-001	Midazolam	Midazolam
76045-002	Midazolam	Midazolam
0641-6057	Midazolam	Midazolam
0641-6056	Midazolam	Midazolam
0641-6059	Midazolam	Midazolam
0641-6061	Midazolam	Midazolam
0641-6063	Midazolam	Midazolam
0641-6060	Midazolam	Midazolam
0641-6210	Midazolam	Midazolam
0641-6211	Midazolam	Midazolam
0641-6190	Midazolam	Midazolam
0641-6209	Midazolam	Midazolam
17478-523	Midazolam	Midazolam
17478-524	Midazolam	Midazolam
47781-589	Midazolam	Midazolam
47781-588	Midazolam	Midazolam
50090-0683	Midazolam	Midazolam
50090-0738	Midazolam	Midazolam
50090-3312	Midazolam	Midazolam
50090-3435	Midazolam	Midazolam
51662-1324	MIDAZOLAM	MIDAZOLAM
51662-1236	MIDAZOLAM	MIDAZOLAM
51662-1237	MIDAZOLAM	MIDAZOLAM
52584-596	Midazolam	Midazolam
52584-055	Midazolam	Midazolam
52584-056	Midazolam	Midazolam
52584-059	Midazolam	Midazolam
52584-589	MIDAZOLAM	MIDAZOLAM
55154-2889	Midazolam	Midazolam
63323-411	Midazolam	Midazolam
63323-412	Midazolam	Midazolam
65293-412	Midazolam	Midazolam
65293-414	Midazolam	Midazolam
65293-416	Midazolam	Midazolam
65293-415	Midazolam	Midazolam
65293-411	Midazolam	Midazolam
65293-413	Midazolam	Midazolam
65293-417	Midazolam	Midazolam
52584-081	Midazolam	Midazolam
0054-3566	Midazolam Hydrochloride	Midazolam Hydrochloride
0404-9916	Midazolam Hydrochloride	Midazolam Hydrochloride
0409-2305	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE
0409-2306	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE