SYNDROS
- Product NDC
- 78613-201
- 11-digit product format
- 786130201
- Labeler code
- 78613
- Product ID
- 78613-201_3e1cbbb1-291c-41bb-b209-93c1fb08313a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dronabinol
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Benuvia Operations, LLC
- Application
- NDA205525
- Marketing category
- NDA
- Marketing start
- 2017-07-01
- Marketing end
- 2027-04-30
- Substance
- DRONABINOL
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Cannabinoid [EPC], Cannabinoids [CS]
- DEA schedule
- CII
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SYNDROS
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DRONABINOL | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7J8897W37S |
| Rxcui | 1928948, 1928954 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78613-201-30 | SYNDROS | 1 in 1 CARTON | SOLUTION | 1 | | 9 |
| 78613-201-30 | SYNDROS | 30 mL in 1 BOTTLE, GLASS | SOLUTION | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78613-201 | SYNDROS (DRONABINOL) SOLUTION [BENUVIA OPERATIONS, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240601_a7801c70-995d-46a2-91ee-141ef427c6b5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 78613-201-30 | 78613020130 | 1 BOTTLE, GLASS in 1 CARTON (78613-201-30) / 30 mL in 1 BOTTLE, GLASS | 2017-07-01 | 2027-04-30 | No | No | Current |