Prescription drug · ANDA
Midazolam Hydrochloride NDC 0054-3566
Midazolam hydrochloride 2 mg/mL · Syrup · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-3566-99 | 0005435669900054356699 | 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.NDC labeler code 0054
- 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 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
N400054356699followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 0054-3566
- What is NDC 0054-3566?
- 0054-3566 is the product NDC for Midazolam Hydrochloride, Midazolam hydrochloride 2 mg/mL syrup, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Midazolam Hydrochloride.
- What is the active ingredient?
- Midazolam hydrochloride.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 Hydrochloride?
- 14 other product NDCs are listed under this name. See all Midazolam Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Midazolam Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Midazolam Hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Jvet Pharmaceuticals LLC | 86211-111 | 86211-0111-10 |
| Midazolam Hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Belcher Pharmaceuticals, LLC | 62250-111 | 62250-0111-10 |
| Midazolam Hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9916 | 00404-9916-0100404-9916-02 |
| Midazolam Hydrochloride | Midazolam hydrochloride 2 mg/mL | SyrupOral | American Health Packaging | 60687-576 | 60687-0576-1060687-0576-86 |
| Midazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-600 | 23155-0600-41 |
| Midazolam hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-601 | 23155-0601-4123155-0601-42 |
| Midazolam Hydrochloride | Midazolam hydrochloride 2 mg/mL | SyrupOral | Precision Dose Inc. | 68094-762 | 68094-0762-62 |
| Midazolam Hydrochloride | Midazolam hydrochloride 2 mg/mL | SyrupOral | Precision Dose Inc. | 68094-764 | 68094-0764-62 |
| Midazolam hydrochloride | Midazolam hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous | Gland Pharma Limited | 68083-106 | 68083-0106-01 |
| Midazolam Hydrochloride | Midazolam hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Gland Pharma Limited | 68083-108 | 68083-0108-0168083-0108-02 |
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 | Precision Dose Inc. | 68094-762 |
| Midazolam Hydrochloride | Midazolam hydrochloride 2 mg/mL | SyrupOral | Precision Dose Inc. | 68094-764 |