NDC codes

FDA NDC Directory
Product NDC (as listed)31722-961Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0961Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
31722-961-603172209616060 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
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

N431722096160 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207421

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207421
ProductStrengthForm · routeLabelerProduct NDC
DronabinolDronabinol 2.5 mg/1CapsuleOralCamber Pharmaceuticals Inc31722-960
DronabinolDronabinol 10 mg/1CapsuleOralCamber Pharmaceuticals Inc31722-962

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in