Prescription drug · NDA
Syndros (dronabinol) NDC 78613-201
Dronabinol 5 mg/mL · Solution · Oral · Benuvia Operations, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78613-201-30 | 78613020130 | 1 BOTTLE, GLASS in 1 CARTON (78613-201-30) / 30 mL in 1 BOTTLE, GLASSMarketed from Jul 1, 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)
- Syndros
- Generic name (nonproprietary)
- dronabinol
- Active ingredients
- Dronabinol — 5 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Benuvia Operations, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205525
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Cannabinoids (Chemical structure)
- Identifiers
- Product ID 78613-201_3e1cbbb1-291c-41bb-b209-93c1fb08313aSPL ID 3e1cbbb1-291c-41bb-b209-93c1fb08313aSPL set ID a7801c70-995d-46a2-91ee-141ef427c6b5RxCUI 1928948, 1928954UNII 7J8897W37SUPC 0378613201306
- 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
N478613020130followed by a unit qualifier and the quantityPackage 78613-0201-30. 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)
SYNDROS 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. SYNDROS 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. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205525
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/mL | SolutionOral | Chartwell RX, LLC | 62135-033 |
| Dronabinol | Dronabinol 5 mg/mL | SolutionOral | Wellhouse Pharma, LLC | 85776-202 |
| Syndrosdronabinol | Dronabinol 5 mg/mL | SolutionOral | Wellhouse Pharma, LLC | 85776-201 |