Prescription drug · NDA
Syndros (dronabinol) NDC 85776-201
Dronabinol 5 mg/mL · Solution · Oral · Wellhouse Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85776-201-30 | 85776020130 | 1 BOTTLE, GLASS in 1 CARTON (85776-201-30) / 30 mL in 1 BOTTLE, GLASSMarketed from Apr 16, 2026 |
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
- Wellhouse Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205525
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Cannabinoids (Chemical structure)
- Identifiers
- Product ID 85776-201_dcc02ae3-f1fa-431e-81bb-c52d35b81c66SPL ID dcc02ae3-f1fa-431e-81bb-c52d35b81c66SPL set ID 3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89RxCUI 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
N485776020130followed by a unit qualifier and the quantityPackage 85776-0201-30. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | Benuvia Operations, LLC | 78613-201 |