Prescription drug · ANDA
Disulfiram NDC 42794-029
Disulfiram 500 mg/1 · Tablet · Oral · Sigmapharm Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42794-029-08 | 42794002908 | 30 TABLET in 1 BOTTLE (42794-029-08)Marketed from Jan 11, 2022 |
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)
- Disulfiram
- Generic name (nonproprietary)
- disulfiram
- Active ingredients
- Disulfiram — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sigmapharm Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091619
- Marketing start
- Listing expires
- Other FDA classes
- Acetyl Aldehyde Dehydrogenase Inhibitors (Mechanism)
- Identifiers
- Product ID 42794-029_20208d67-134d-2cc1-e063-6394a90a59beSPL ID 20208d67-134d-2cc1-e063-6394a90a59beSPL set ID 40f5497f-fe84-43b2-8ff4-32d59edf3917RxCUI 197623, 197624UNII TR3MLJ1UAIUPC 0342794028083
- Pharmacologic class
- Aldehyde Dehydrogenase Inhibitor
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
N442794002908followed by a unit qualifier and the quantityPackage 42794-0029-08. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE: Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091619
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 |
|---|---|---|---|---|
| Disulfiram | Disulfiram 250 mg/1 | TabletOral | Sigmapharm Laboratories, LLC | 42794-028 |