MARINOL
- Product NDC
- 53097-571
- 11-digit product format
- 530970571
- Labeler code
- 53097
- Product ID
- 53097-571_5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dronabinol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ThePharmaNetwork, LLC
- Application
- NDA018651
- Marketing category
- NDA
- Marketing start
- 2021-03-03
- Substance
- DRONABINOL
- Active strength
- 2.5 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 | 2.5 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 |
|---|
| 53097-571-60 | MARINOL | 60 in 1 BOTTLE | CAPSULE | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53097-571 | MARINOL (DRONABINOL) CAPSULE [THEPHARMANETWORK, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230215_d0efeeec-640d-43c3-8f0a-d31324a11c68.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 |
|---|
| 53097-571-60 | 53097057160 | 60 CAPSULE in 1 BOTTLE (53097-571-60) | 60 capsule | 2021-03-03 | 0000-00-00 | No | No | Current |