NDC 47781-589

Midazolam

Midazolam Hydrochloride

Midazolam is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Alvogen Inc.. The primary component is Midazolam Hydrochloride.

• Product ID: 47781-589_6ecc698c-b49e-cddf-0ce3-8b8e1391aab6
• NDC: 47781-589
• Product Type: Human Prescription Drug
• Proprietary Name: Midazolam
• Generic Name: Midazolam Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2017-08-11
• Marketing End Date: 2023-06-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090850
• Labeler Name: Alvogen Inc.
• Substance Name: MIDAZOLAM HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: N

Packaging

NDC 47781-589-91

10 VIAL, MULTI-DOSE in 1 CARTON (47781-589-91) > 10 mL in 1 VIAL, MULTI-DOSE (47781-589-22)

• Marketing Start Date: 2017-08-11
• Marketing End Date: 2023-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47781-589-22 [47781058922]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090850
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-08-11

NDC 47781-589-17 [47781058917]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090850
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-08-11

NDC 47781-589-20 [47781058920]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090850
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-08-11

NDC 47781-589-91 [47781058991]

Midazolam INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090850
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-08-11

Drug Details

Active Ingredients

Ingredient	Strength
MIDAZOLAM HYDROCHLORIDE	5 mg/mL

OpenFDA Data

• SPL SET ID: 68ec2393-b5aa-ce93-5382-a53af6885ad7
• Manufacturer:
  • Alvogen Inc.
• UNII:
  • W7TTW573JJ
• RxNorm Concept Unique ID - RxCUI:
  • 311702

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]

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