Prescription drug · ANDA
Midodrine Hydrochloride NDC 59651-247
Midodrine hydrochloride 5 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-247-01 | 59651024701 | 1 BOTTLE in 1 CARTON (59651-247-01) / 100 TABLET in 1 BOTTLEMarketed from Aug 10, 2020 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212774
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 59651-247_fc0c51f9-da23-4083-ae88-c4bd5d8ad44bSPL ID fc0c51f9-da23-4083-ae88-c4bd5d8ad44bSPL set ID 771b3e81-f15b-4d32-a1d8-c43b104d1f7bRxCUI 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
N459651024701followed by a unit qualifier and the quantityPackage 59651-0247-01. 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’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 midodri…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212774
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 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3037 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-246 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-248 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2560 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2559 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2561 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8382 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8383 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8384 |