Dronabinol
- Product NDC
- 0904-7145
- 11-digit product format
- 009047145
- Labeler code
- 0904
- Product ID
- 0904-7145_f9804c15-4d58-415f-be1b-28fd387774bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dronabinol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- NDA018651
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2021-03-03
- Substance
- DRONABINOL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cannabinoid [EPC], Cannabinoids [CS]
- DEA schedule
- CIII
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7J8897W37S |
| Rxcui | 197635, 197636 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7145-04 | Dronabinol | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 6 |
| 0904-7145-04 | Dronabinol | 30 in 1 CARTON | CAPSULE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7145 | DRONABINOL CAPSULE [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250131_fd8c5d57-0173-4f62-8ff0-d8147986a976.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 |
|---|
| 0904-7145-04 | 00904714504 | 30 BLISTER PACK in 1 CARTON (0904-7145-04) / 1 CAPSULE in 1 BLISTER PACK | 30 blister pack | 2021-03-03 | 0000-00-00 | No | No | Current |