MIDODRINE HYDROCHLORIDE
- Product NDC
- 46708-339
- 11-digit product format
- 467080339
- Labeler code
- 46708
- Product ID
- 46708-339_38173ca4-7b7e-4c91-b12c-7cce5bfaba84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MIDODRINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA214734
- Marketing category
- ANDA
- Marketing start
- 2021-01-22
- 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 |
|---|
| 46708-339-31 | MIDODRINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 46708-339-71 | MIDODRINE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-339 | MIDODRINE HYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230129_03b54024-2a26-4abe-bd8b-b66bb6781fa7.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 |
|---|
| 46708-339-31 | 46708033931 | 100 TABLET in 1 BOTTLE (46708-339-31) | 100 tablet | 2021-01-22 | 0000-00-00 | No | No | Current |
| 46708-339-71 | 46708033971 | 500 TABLET in 1 BOTTLE (46708-339-71) | 500 tablet | 2021-01-22 | 0000-00-00 | No | No | Current |