Prescription drug · NDA
Dronabinol NDC 62135-033
Dronabinol 5 mg/mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-033-43 | 62135003343 | 1 BOTTLE, GLASS in 1 CARTON (62135-033-43) / 30 mL in 1 BOTTLE, GLASSMarketed from Jan 26, 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)
- Dronabinol
- Generic name (nonproprietary)
- dronabinol
- Active ingredients
- Dronabinol — 5 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- 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 62135-033_4954c560-9d61-5d0f-e063-6394a90a7c5bSPL ID 4954c560-9d61-5d0f-e063-6394a90a7c5bSPL set ID 44205ae6-b86a-485c-baf6-233a2c878640RxCUI 1928948UNII 7J8897W37SUPC 0362135033439
- 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
N462135003343followed by a unit qualifier and the quantityPackage 62135-0033-43. 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)
Dronabinol oral solution 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. Dronabinol oral solution 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 62135-033
- What is NDC 62135-033?
- 62135-033 is the product NDC for Dronabinol, Dronabinol 5 mg/mL solution, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dronabinol.
- What is the active ingredient?
- Dronabinol.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dronabinol?
- 9 other product NDCs are listed under this name. See all Dronabinol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dronabinol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dronabinol | Dronabinol 5 mg/mL | SolutionOral | Wellhouse Pharma, LLC | 85776-202 | 85776-0202-30 |
| Dronabinol | Dronabinol 5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7145 | 00904-7145-04 |
| Dronabinol | Dronabinol 10 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-755 | 67877-0755-60 |
| Dronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-753 | 67877-0753-60 |
| Dronabinol | Dronabinol 5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-754 | 67877-0754-60 |
| Dronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7144 | 00904-7144-61 |
| Dronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | Camber Pharmaceuticals Inc | 31722-960 | 31722-0960-60 |
| Dronabinol | Dronabinol 5 mg/1 | CapsuleOral | Camber Pharmaceuticals Inc | 31722-961 | 31722-0961-60 |
| Dronabinol | Dronabinol 10 mg/1 | CapsuleOral | Camber Pharmaceuticals Inc | 31722-962 | 31722-0962-60 |
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 |
| Syndrosdronabinol | Dronabinol 5 mg/mL | SolutionOral | Wellhouse Pharma, LLC | 85776-201 |