Prescription drug · ANDA
Midodrine Hydrochloride NDC 82293-004
Midodrine hydrochloride 5 mg/1 · Tablet · Oral · Novugen Pharma (USA) LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82293-004-10 | 8229300041082293000410 | 100 TABLET in 1 BOTTLE (82293-004-10)Marketed from Oct 18, 2023 |
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
- Novugen Pharma (USA) LLCNDC labeler code 82293
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211973
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 82293-004_451b5336-7460-7ffc-e063-6294a90aa15bSPL ID 451b5336-7460-7ffc-e063-6294a90aa15bSPL set ID 2bf011fe-d114-42a4-93e2-76a993a3ba34RxCUI 993462, 993466, 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
N482293000410followed by a unit qualifier and the quantityPackage 82293-0004-10. 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 82293-004
- What is NDC 82293-004?
- 82293-004 is the product NDC for Midodrine Hydrochloride, Midodrine hydrochloride 5 mg/1 tablet, listed with the FDA by Novugen Pharma (USA) LLC. 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?
- Novugen Pharma (USA) LLC, NDC labeler code 82293. 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 211973
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 | Novugen Pharma (USA) LLC | 82293-003 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Novugen Pharma (USA) LLC | 82293-005 |