What is NDC 71053-595?

71053-595 is the product NDC for Midazolam Injection, 10 mg, Midazolam 10 mg/.7mL injection, solution, listed with the FDA by Rafa Laboratories, Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rafa Laboratories, Ltd., NDC labeler code 71053. 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 Injection, 10 mg?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Midazolam Injection, 10 mg NDC 71053-595

NDC codes

FDA NDC Directory

Product NDC (as listed)71053-595Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71053-0595Add 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
71053-595-01	71053059501	480 CARTON in 1 BOX (71053-595-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGEMarketed from Aug 8, 2022

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

Generic name (nonproprietary): midazolam injection, 10 mg
Active ingredients: Midazolam — 10 mg/.7mL
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: Rafa Laboratories, Ltd.NDC labeler code 71053
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216359
Marketing start: Aug 8, 2022
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 71053-595_4b1cba4c-3cc1-5642-e063-6294a90a4522SPL ID 4b1cba4c-3cc1-5642-e063-6294a90a4522SPL set ID d7362b4d-68a3-99a0-e053-2995a90a4f60RxCUI 2608698UNII R60L0SM5BC
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

N471053059501 followed by a unit qualifier and the quantity

Package 71053-0595-01. 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

Current FDA label (SPL), effective Feb 18, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Midazolam Injection is indicated for the treatment of status epilepticus in adults. Midazolam Injection is a benzodiazepine indicated for the treatment of status epilepticus in adults. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71053-595

What is NDC 71053-595?: 71053-595 is the product NDC for Midazolam Injection, 10 mg, Midazolam 10 mg/.7mL injection, solution, listed with the FDA by Rafa Laboratories, Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Midazolam Injection, 10 mg.
What is the active ingredient?: Midazolam.
Who is the labeler?: Rafa Laboratories, Ltd., NDC labeler code 71053. 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 Injection, 10 mg?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.