Prescription drug · ANDA
Midodrine Hydrochloride NDC 63629-2227
Midodrine hydrochloride 2.5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2227-1 | 63629222701 | 100 TABLET in 1 BOTTLE (63629-2227-1)Marketed from Mar 22, 2021 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207169
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 63629-2227_eeb7ab44-53b0-47d6-b23f-badbebb8b231SPL ID eeb7ab44-53b0-47d6-b23f-badbebb8b231SPL set ID 5a6705af-bb72-4edb-863a-93a351bd6dbaRxCUI 993466UNII 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
N463629222701followed by a unit qualifier and the quantityPackage 63629-2227-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP 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, USP effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clini…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207169
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 5 mg/1 | TabletOral | Par Health USA, LLC | 49884-849 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Par Health USA, LLC | 49884-814 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Par Health USA, LLC | 49884-874 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1517 |