Midodrine hydrochloride
- Product NDC
- 68382-738
- 11-digit product format
- 683820738
- Labeler code
- 68382
- Product ID
- 68382-738_fe679311-db62-4004-800d-2961962340de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midodrine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA213055
- Marketing category
- ANDA
- Marketing start
- 2020-09-17
- Substance
- MIDODRINE HYDROCHLORIDE
- Active strength
- 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 | 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 |
|---|
| 68382-738-01 | 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 |
|---|
| 68382-738 | MIDODRINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240328_3bc97210-fa2f-4979-abdf-d92e5973e6e3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-738-01 | 68382073801 | 100 TABLET in 1 BOTTLE (68382-738-01) | 100 tablet | 2020-09-17 | 0000-00-00 | No | No | Current |