droxidopa
- Product NDC
- 63304-104
- 11-digit product format
- 633040104
- Labeler code
- 63304
- Product ID
- 63304-104_ca97f06d-5449-4f4f-a362-47f65448bf8c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- droxidopa
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA214384
- Marketing category
- ANDA
- Marketing start
- 2021-02-18
- Substance
- DROXIDOPA
- Active strength
- 200 ug/1
- Pharmacologic classes
- Catecholamines [CS], Increased Blood Pressure [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- droxidopa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DROXIDOPA | 200 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J7A92W69L7 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-104-90 | droxidopa | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-104 | DROXIDOPA CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20210223_51ef3096-4622-4f45-a180-ab0dc6d46df9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63304-104-90 | 63304010490 | 90 CAPSULE in 1 BOTTLE (63304-104-90) | 90 capsule | 2021-02-18 | 0000-00-00 | No | No | Current |