Prescription drug · ANDA
Midodrine Hydrochloride NDC 85293-007
Midodrine hydrochloride 10 mg/1 · Tablet · Oral · Umasuto, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85293-007-01 | 85293000701 | 100 TABLET in 1 BOTTLE (85293-007-01)Marketed from Mar 5, 2025 |
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
- Umasuto, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207613
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 85293-007_2fb355a4-09cf-880d-e063-6394a90a8178SPL ID 2fb355a4-09cf-880d-e063-6394a90a8178SPL set ID 4f5e1689-9691-471b-a39c-26120d6ce073RxCUI 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
N485293000701followed by a unit qualifier and the quantityPackage 85293-0007-01. 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'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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207613
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 | Bryant Ranch Prepack | 71335-1705 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-434 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-433 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-435 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Umasuto, LLC | 85293-005 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Umasuto, LLC | 85293-006 |