Midazolam Hydrochloride NDC 0404-9916

NDC codes

FDA NDC Directory

Product NDC (as listed)0404-9916Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00404-9916Add 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
0404-9916-01	00404991601	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 17, 2022
0404-9916-02	00404991602	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9916-02) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 17, 2022

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 — 5 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Henry Schein, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075857
Marketing start: Jan 17, 2022
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 0404-9916_cf4854ec-c2d6-486d-9712-ffe9dac99926SPL ID cf4854ec-c2d6-486d-9712-ffe9dac99926SPL set ID 9e3bd5d3-36b3-471c-b8cc-ef48645700c2RxCUI 1666814, 1666823UNII 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 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

N400404991601 followed by a unit qualifier and the quantity

Package 00404-9916-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 075857

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

FDA NDC Directory listings under ANDA 075857
Product	Strength	Form · route	Labeler	Product NDC
Midazolammidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-0001
Midazolammidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-2305
Midazolammidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-2305
Midazolammidazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-2308
Midazolammidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-4743
Midazolammidazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-2308