DRONABINOL
- Product NDC
- 31722-961
- 11-digit product format
- 317220961
- Labeler code
- 31722
- Product ID
- 31722-961_dd59cbf6-b383-4c39-ae06-2c7ea4de966a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dronabinol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals Inc
- Application
- ANDA207421
- Marketing category
- ANDA
- Marketing start
- 2020-02-10
- 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 | 197634, 197635, 197636 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-961-60 | DRONABINOL | 60 in 1 BOTTLE | CAPSULE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-961 | DRONABINOL CAPSULE [CAMBER PHARMACEUTICALS INC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20200317_66f36fe0-9808-4b73-a99a-794d86ff0c1c.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 |
|---|
| 31722-961-60 | 31722096160 | 60 CAPSULE in 1 BOTTLE (31722-961-60) | 60 capsule | 2020-02-10 | 0000-00-00 | No | No | Current |