Midazolam Hydrochloride NDC 0054-3566

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-3566Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-3566Add 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
0054-3566-99	00054356699	118 mL in 1 BOTTLE, GLASS (0054-3566-99)Marketed from Apr 30, 2002

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: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075873
Marketing start: Apr 30, 2002
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 0054-3566_fba22894-bfd7-4332-9d8b-34fc48389520SPL ID fba22894-bfd7-4332-9d8b-34fc48389520SPL set ID a833c24b-6dca-44d7-a0d6-20012fa1ea77RxCUI 422410UNII W7TTW573JJUPC 0300543566996
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

N400054356699 followed by a unit qualifier and the quantity

Package 00054-3566-99. 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 Apr 29, 2025. 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 075873

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

FDA NDC Directory listings under ANDA 075873
Product	Strength	Form · route	Labeler	Product NDC
Midazolam Hydrochloride	Midazolam hydrochloride 2 mg/mL	SyrupOral	American Health Packaging	60687-576
Midazolam Hydrochloride	Midazolam hydrochloride 2 mg/mL	SyrupOral	Precision Dose Inc.	68094-762
Midazolam Hydrochloride	Midazolam hydrochloride 2 mg/mL	SyrupOral	Precision Dose Inc.	68094-764