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 | 5107904532051079045320 | 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.NDC labeler code 51079
- 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
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' 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 o…
Excerpt only. Read the full label for complete information.
About NDC 51079-453
- What is NDC 51079-453?
- 51079-453 is the product NDC for Midodrine Hydrochloride, Midodrine hydrochloride 5 mg/1 tablet, listed with the FDA by Mylan Institutional Inc.. It has 1 package NDC, 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?
- Mylan Institutional Inc., NDC labeler code 51079. 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 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7641 | 00904-7641-0600904-7641-61 |
| 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 |
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 | Safecor Health LLC | 48433-075 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5696 |