Prescription drug · ANDA
Midodrine Hydrochloride NDC 0904-7641
Midodrine hydrochloride 5 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7641-06 | 0090476410600904764106 | 5 BLISTER PACK in 1 CARTON (0904-7641-06) / 10 TABLET in 1 BLISTER PACK (0904-7641-35)Marketed from Sep 1, 2026 | |
| 0904-7641-61 | 0090476416100904764161 | 10 BLISTER PACK in 1 CARTON (0904-7641-61) / 10 TABLET in 1 BLISTER PACK (0904-7641-35)Marketed from Sep 1, 2026 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- 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 0904-7641_b25bca12-95e2-4fbe-b1d6-7bd96bf1aa3bSPL ID b25bca12-95e2-4fbe-b1d6-7bd96bf1aa3b
- 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
N400904764106followed by a unit qualifier and the quantityPackage 00904-7641-06. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0904-7641
- What is NDC 0904-7641?
- 0904-7641 is the product NDC for Midodrine Hydrochloride, Midodrine hydrochloride 5 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Midodrine Hydrochloride.
- What is the active ingredient?
- Midodrine hydrochloride.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Midodrine Hydrochloride?
- 108 other product NDCs are listed under this name. See all Midodrine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Midodrine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7640 | 00904-7640-0600904-7640-61 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7642 | 00904-7642-07 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-906 | 72603-0906-0572603-0906-10 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-907 | 72603-0907-0572603-0907-10 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-908 | 72603-0908-0372603-0908-05 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Avet Pharmaceuticals Inc. | 23155-969 | 23155-0969-01 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Avet Pharmaceuticals Inc. | 23155-970 | 23155-0970-01 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Avet Pharmaceuticals Inc. | 23155-971 | 23155-0971-01 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Safecor Health LLC | 48433-075 | 48433-0075-20 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | First Nation Group, LLC | 81469-139 | 81469-0139-90 |
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 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7640 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7642 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-1512 |
| 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 | 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 | First Nation Group, LLC | 81469-139 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | First Nation Group, LLC | 81469-140 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-141 |