Prescription drug · ANDA
Midodrine Hydrochloride NDC 50268-563
Midodrine hydrochloride 10 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-563-15 | 50268056315 | 50 TABLET in 1 BOX (50268-563-15)Marketed from Aug 26, 2019 |
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)
- Midodrine Hydrochloride
- Generic name (nonproprietary)
- midodrine hydrochloride
- Active ingredients
- Midodrine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077746
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 50268-563_32fa2977-8701-5efb-e063-6394a90a2dffSPL ID 32fa2977-8701-5efb-e063-6394a90a2dffSPL set ID 9106776e-601a-4e3c-e053-2995a90a5435RxCUI 993462, 993466, 993470UNII 59JV96YTXV
- Pharmacologic class
- alpha-Adrenergic Agonist
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
N450268056315followed by a unit qualifier and the quantityPackage 50268-0563-15. 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 Midodrine hydrochloride is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride 's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077746
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 |
|---|---|---|---|---|
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8086 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1433 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4174 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | AvKARE | 42291-560 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | AvKARE | 42291-561 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | AvKARE | 42291-562 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | AvPAK | 50268-561 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | AvPAK | 50268-562 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6817 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6818 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6819 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | American Health Packaging | 60687-387 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-398 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-409 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Apotex Corp | 60505-1321 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Apotex Corp | 60505-1320 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Apotex Corp | 60505-1325 |