Prescription drug · ANDA
Midazolam Hydrochloride NDC 68094-762
Midazolam hydrochloride 2 mg/mL · Syrup · Oral · Precision Dose Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-762-62 | 68094076262 | 3 TRAY in 1 CASE (68094-762-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 2.5 mL in 1 CUP, UNIT-DOSE (68094-762-59)Marketed from May 26, 2015 |
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 Hydrochloride
- Generic name (nonproprietary)
- midazolam hydrochloride
- Active ingredients
- Midazolam hydrochloride — 2 mg/mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Precision Dose Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075873
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 68094-762_8b065244-dc26-4da0-9e51-42989976fdfbSPL ID 8b065244-dc26-4da0-9e51-42989976fdfbSPL set ID 557ef7bf-9341-47f9-804d-430a24982fa6RxCUI 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
N468094076262followed by a unit qualifier and the quantityPackage 68094-0762-62. 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 . 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.
Other NDCs under ANDA 075873
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Hikma Pharmaceuticals USA Inc. | 0054-3566 |
| Midazolam Hydrochloride | Midazolam hydrochloride 2 mg/mL | SyrupOral | Precision Dose Inc. | 68094-764 |