Prescription drug · ANDA
Midodrine Hydrochloride NDC 67046-1512
Midodrine hydrochloride 5 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1512-3 | 67046151203 | 30 TABLET in 1 BLISTER PACK (67046-1512-3)Marketed from Feb 1, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217271
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 67046-1512_2d1b581e-1683-9af6-e063-6394a90ac136SPL ID 2d1b581e-1683-9af6-e063-6394a90ac136SPL set ID 2d1b58a7-ec7f-f3ea-e063-6294a90a27fbRxCUI 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
N467046151203followed by a unit qualifier and the quantityPackage 67046-1512-03. 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 217271
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 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-141 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | First Nation Group, LLC | 81469-139 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | First Nation Group, LLC | 81469-140 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-906 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-907 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-908 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-010 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-049 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-050 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7640 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7641 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7642 |