Prescription drug · ANDA
Dronabinol NDC 31722-961
Dronabinol 5 mg/1 · Capsule · Oral · Camber Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-961-60 | 31722096160 | 60 CAPSULE in 1 BOTTLE (31722-961-60)Marketed from Feb 10, 2020 |
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/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207421
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Cannabinoids (Chemical structure)
- Identifiers
- Product ID 31722-961_dd59cbf6-b383-4c39-ae06-2c7ea4de966aSPL ID dd59cbf6-b383-4c39-ae06-2c7ea4de966aSPL set ID 66f36fe0-9808-4b73-a99a-794d86ff0c1cRxCUI 197634, 197635, 197636UNII 7J8897W37SUPC 0331722961608, 0331722962605, 0331722960601
- 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
N431722096160followed by a unit qualifier and the quantityPackage 31722-0961-60. 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)
Dronabinol capsules are 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 capsules are 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 ANDA 207421
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 2.5 mg/1 | CapsuleOral | Camber Pharmaceuticals Inc | 31722-960 |
| Dronabinol | Dronabinol 10 mg/1 | CapsuleOral | Camber Pharmaceuticals Inc | 31722-962 |