Dronabinol
- Product NDC
- 62135-033
- 11-digit product format
- 621350033
- Labeler code
- 62135
- Product ID
- 62135-033_4954c560-9d61-5d0f-e063-6394a90a7c5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dronabinol
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- NDA205525
- Marketing category
- NDA
- Marketing start
- 2017-07-01
- Substance
- DRONABINOL
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Cannabinoid [EPC], Cannabinoids [CS]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dronabinol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DRONABINOL | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7J8897W37S |
| Rxcui | 1928948 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-033-43 | Dronabinol | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 62135-033-43 | Dronabinol | 30 mL in 1 BOTTLE, GLASS | SOLUTION | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-033-43 | 62135003343 | 1 BOTTLE, GLASS in 1 CARTON (62135-033-43) / 30 mL in 1 BOTTLE, GLASS | 2026-01-26 | No | No | Current |