Prescription drug · NDA
Marinol (Dronabinol) NDC 53097-569
Dronabinol 5 mg/1 · Capsule · Oral · ThePharmaNetwork, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53097-569-60 | 53097056960 | 1 BOTTLE in 1 CARTON (53097-569-60) / 60 CAPSULE in 1 BOTTLEMarketed from May 10, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Marinol
- Generic name (nonproprietary)
- dronabinol
- Active ingredients
- Dronabinol — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ThePharmaNetwork, LLCNDC labeler code 53097
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018651
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Cannabinoids (Chemical structure)
- Identifiers
- Product ID 53097-569_628f9609-6583-49be-be77-b64cfbc46fd7SPL ID 628f9609-6583-49be-be77-b64cfbc46fd7SPL set ID 628f9609-6583-49be-be77-b64cfbc46fd7RxCUI 197634, 197635, 197636, 205641, 205642, 205645UNII 7J8897W37SUPC 0353097569609, 0353097570605, 0353097568602
- Pharmacologic class
- Cannabinoid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N453097056960followed by a unit qualifier and the quantityPackage 53097-0569-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
MARINOL is indicated in adults for the treatment of: • anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). • nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. MARINOL is a cannabinoid indicated in adults for the treatment of: • Anorexia associated with weight loss in patients with AIDS. (1) • Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
Excerpt only. Read the full label for complete information.
About NDC 53097-569
- What is NDC 53097-569?
- 53097-569 is the product NDC for Marinol (dronabinol), Dronabinol 5 mg/1 capsule, listed with the FDA by ThePharmaNetwork, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Marinol (Dronabinol).
- What is the active ingredient?
- Dronabinol.
- Who is the labeler?
- ThePharmaNetwork, LLC, NDC labeler code 53097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Marinol?
- 5 other product NDCs are listed under this name. See all Marinol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Marinol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Marinoldronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-571 | 53097-0571-60 |
| Marinoldronabinol | Dronabinol 5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-572 | 53097-0572-60 |
| Marinoldronabinol | Dronabinol 10 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-573 | 53097-0573-60 |
| Marinoldronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-568 | 53097-0568-60 |
| Marinoldronabinol | Dronabinol 10 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-570 | 53097-0570-60 |
Other NDCs under NDA 018651
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dronabinol | Dronabinol 5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-754 |
| Dronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-753 |
| Dronabinol | Dronabinol 10 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-755 |
| Dronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7144 |
| Dronabinol | Dronabinol 5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7145 |
| Marinoldronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-568 |
| Marinoldronabinol | Dronabinol 10 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-570 |
| Marinoldronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-571 |
| Marinoldronabinol | Dronabinol 5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-572 |
| Marinoldronabinol | Dronabinol 10 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-573 |