Prescription drug · NDA AUTHORIZED GENERIC
Dronabinol NDC 0904-7145
Dronabinol 5 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7145-04 | 00904714504 | 30 BLISTER PACK in 1 CARTON (0904-7145-04) / 1 CAPSULE in 1 BLISTER PACKMarketed from Mar 3, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 018651
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Cannabinoids (Chemical structure)
- Identifiers
- Product ID 0904-7145_f9804c15-4d58-415f-be1b-28fd387774bdSPL ID f9804c15-4d58-415f-be1b-28fd387774bdSPL set ID fd8c5d57-0173-4f62-8ff0-d8147986a976RxCUI 197635, 197636UNII 7J8897W37S
- 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
N400904714504followed by a unit qualifier and the quantityPackage 00904-7145-04. 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 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 0904-7145
- What is NDC 0904-7145?
- 0904-7145 is the product NDC for Dronabinol, Dronabinol 5 mg/1 capsule, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 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 |
| Dronabinol | Dronabinol 5 mg/mL | SolutionOral | Chartwell RX, LLC | 62135-033 | 62135-0033-43 |
Other NDCs under NDA 018651
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 | Ascend Laboratories, LLC | 67877-753 |
| Dronabinol | Dronabinol 5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-754 |
| Dronabinol | Dronabinol 10 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-755 |
| Dronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7144 |
| Marinoldronabinol | Dronabinol 5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-569 |
| Marinoldronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-568 |
| Marinoldronabinol | Dronabinol 5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-572 |
| Marinoldronabinol | Dronabinol 10 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-570 |
| Marinoldronabinol | Dronabinol 2.5 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-571 |
| Marinoldronabinol | Dronabinol 10 mg/1 | CapsuleOral | ThePharmaNetwork, LLC | 53097-573 |