Midazolam Hydrochloride NDC 0574-0150

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-0150Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-0150Add 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
0574-0150-04	00574015004	1 BOTTLE, GLASS in 1 CARTON (0574-0150-04) / 118 mL in 1 BOTTLE, GLASSMarketed from May 2, 2005

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 Hydrochloride
Generic name (nonproprietary): midazolam hydrochloride
Active ingredients: Midazolam hydrochloride — 2 mg/mL
Dosage form: Syrup
Route: Oral
Labeler: Padagis US LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076379
Marketing start: May 2, 2005
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 0574-0150_d7b8dd9f-1acd-4d10-afbf-a57a93154a6bSPL ID d7b8dd9f-1acd-4d10-afbf-a57a93154a6bSPL set ID 0be63f63-6a93-4782-8f9c-d13ca5ae44bdRxCUI 422410UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400574015004 followed by a unit qualifier and the quantity

Package 00574-0150-04. 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 Dec 6, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use [see WARNINGS] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076379

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

FDA NDC Directory listings under ANDA 076379
Product	Strength	Form · route	Labeler	Product NDC
Midazolam Hydrochloride	Midazolam hydrochloride 2 mg/mL	SyrupOral	Bryant Ranch Prepack	72162-1109