Prescription drug · ANDA
Midodrine Hydrochloride NDC 0378-1903
Midodrine hydrochloride 10 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-1903-01 | 00378190301 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-1903-01)Marketed from Sep 11, 2003 |
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)
- Midodrine Hydrochloride
- Generic name (nonproprietary)
- midodrine hydrochloride
- Active ingredients
- Midodrine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076577
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 0378-1903_e92f278e-0a58-49e3-8fc0-3a16b8474d3bSPL ID e92f278e-0a58-49e3-8fc0-3a16b8474d3bSPL set ID 32fad00b-7e7b-4d35-9e8b-fdc979fdb88eRxCUI 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
N400378190301followed by a unit qualifier and the quantityPackage 00378-1903-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets 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 tablets' 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 o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076577
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 | Mylan Institutional Inc. | 51079-453 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1901 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1902 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5696 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Safecor Health LLC | 48433-075 |