What is NDC 42571-415?

42571-415 is the product NDC for Midazolam, Midazolam hydrochloride 5 mg/mL injection, solution, listed with the FDA by Micro Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Midazolam?

49 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Midazolam NDC 42571-415 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-415Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0415Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42571-415-72	4257104157242571041572	10 VIAL in 1 CARTON (42571-415-72) / 1 mL in 1 VIAL (42571-415-54)Marketed from Jan 1, 2024
42571-415-91	4257104159142571041591	10 VIAL in 1 CARTON (42571-415-91) / 2 mL in 1 VIAL (42571-415-75)Marketed from Jan 1, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Solution
Route: Intramuscular, Intravenous
Labeler: Micro Labs LimitedNDC labeler code 42571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217504
Marketing start: Jan 1, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 42571-415_03a665f9-f328-83d4-e063-6294a90a756aSPL ID 03a665f9-f328-83d4-e063-6294a90a756aSPL set ID 9221894f-d840-46f2-a11c-6b71358d3b5bRxCUI 1666798, 1666814, 1666823UNII W7TTW573JJUPC 0342571415754, 0342571415549, 0342571415914, 0342571415723, 0342571414757
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.

How CPT relates to drug billing

NDC on a medical claim

N442571041572 followed by a unit qualifier and the quantity

Package 42571-0415-72. 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 Aug 24, 2023. 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.

Full label on DailyMed (opens in a new tab)

About NDC 42571-415

What is NDC 42571-415?: 42571-415 is the product NDC for Midazolam, Midazolam hydrochloride 5 mg/mL injection, solution, listed with the FDA by Micro Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Midazolam.
What is the active ingredient?: Midazolam hydrochloride.
Who is the labeler?: Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Midazolam?: 49 other product NDCs are listed under this name. See all Midazolam NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Midazolam NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Midazolammidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-170	83270-0170-10
Midazolammidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-171	83270-0171-10
Midazolammidazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-172	83270-0172-10
Midazolammidazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-173	83270-0173-10
Midazolammidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-174	83270-0174-10
Midazolammidazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-175	83270-0175-10
Midazolammidazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Onesource Specialty Pharma Limited	83270-176	83270-0176-10
Midazolam	Midazolam hydrochloride 1 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9780	00404-9780-10
Midazolammidazolam hydrochloride	Midazolam hydrochloride 2 mg/2mL	Injection, SolutionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4328	70518-4328-00
Midazolammidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-0001	00409-0001-25

All 50 Midazolam NDCs

Other NDCs under ANDA 217504

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217504
Product	Strength	Form · route	Labeler	Product NDC
Midazolam	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Micro Labs Limited	42571-414