Midodrine Hydrochloride
- Product NDC
- 82293-003
- 11-digit product format
- 822930003
- Labeler code
- 82293
- Product ID
- 82293-003_451b5336-7460-7ffc-e063-6294a90aa15b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midodrine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novugen Pharma (USA) LLC
- Application
- ANDA211973
- Marketing category
- ANDA
- Marketing start
- 2023-10-18
- Substance
- MIDODRINE HYDROCHLORIDE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Midodrine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIDODRINE HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 59JV96YTXV |
| Rxcui | 993462, 993466, 993470 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82293-003-10 | Midodrine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82293-003 | MIDODRINE HYDROCHLORIDE TABLET [NOVUGEN PHARMA (USA) LLC] | 2 | Current NDC, 1 package rows | 20240820_2bf011fe-d114-42a4-93e2-76a993a3ba34.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82293-003-10 | 82293000310 | 100 TABLET in 1 BOTTLE (82293-003-10) | 100 tablet | 2023-10-18 | No | No | Historical |