Marinol
- Product NDC
- 53097-570
- 11-digit product format
- 530970570
- Labeler code
- 53097
- Product ID
- 53097-570_628f9609-6583-49be-be77-b64cfbc46fd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dronabinol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ThePharmaNetwork, LLC
- Application
- NDA018651
- Marketing category
- NDA
- Marketing start
- 2017-05-10
- Substance
- DRONABINOL
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cannabinoid [EPC], Cannabinoids [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Marinol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DRONABINOL | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7J8897W37S |
| Rxcui | 197634, 197635, 197636, 205641, 205642, 205645 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53097-570-60 | Marinol | 1 in 1 CARTON | CAPSULE | 1 | | 1 |
| 53097-570-60 | Marinol | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53097-570 | MARINOL (DRONABINOL) CAPSULE [THEPHARMANETWORK, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20200412_628f9609-6583-49be-be77-b64cfbc46fd7.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 |
|---|
| 53097-570-60 | 53097057060 | 1 BOTTLE in 1 CARTON (53097-570-60) / 60 CAPSULE in 1 BOTTLE | 1 bottle | 2017-05-10 | 0000-00-00 | No | No | Current |