Prescription drug · ANDA
Midodrine Hydrochloride NDC 51079-453
Midodrine hydrochloride 5 mg/1 · Tablet · Oral · Mylan Institutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-453-20 | 51079045320 | 100 BLISTER PACK in 1 CARTON (51079-453-20) / 1 TABLET in 1 BLISTER PACK (51079-453-01)Marketed from Sep 11, 2006 |
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
- Mylan Institutional 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 51079-453_3a8743bb-679f-ae20-e063-6394a90a41c6SPL ID 3a8743bb-679f-ae20-e063-6394a90a41c6SPL set ID fd28d383-add9-42a9-ad07-4d7e89f12460RxCUI 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
N451079045320followed by a unit qualifier and the quantityPackage 51079-0453-20. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 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 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1903 |
| 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 |