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, LLCNDC labeler code 85776
- 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
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.
About NDC 85776-201
- What is NDC 85776-201?
- 85776-201 is the product NDC for Syndros (dronabinol), Dronabinol 5 mg/mL solution, listed with the FDA by Wellhouse Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Syndros (Dronabinol).
- What is the active ingredient?
- Dronabinol.
- Who is the labeler?
- Wellhouse Pharma, LLC, NDC labeler code 85776. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Syndros?
- 1 other product NDC are listed under this name. See all Syndros NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Syndros products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Syndrosdronabinol | Dronabinol 5 mg/mL | SolutionOral | Benuvia Operations, LLC | 78613-201 | 78613-0201-30 |
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 |
|---|---|---|---|---|
| Syndrosdronabinol | Dronabinol 5 mg/mL | SolutionOral | Benuvia Operations, LLC | 78613-201 |
| Dronabinol | Dronabinol 5 mg/mL | SolutionOral | Wellhouse Pharma, LLC | 85776-202 |
| Dronabinol | Dronabinol 5 mg/mL | SolutionOral | Chartwell RX, LLC | 62135-033 |