Prescription drug · ANDA
Diazepam NDC 61919-409
Diazepam 5 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-409-02 | 61919040902 | 2 TABLET in 1 BOTTLE (61919-409-02)Marketed from Nov 18, 2019 |
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)
- Diazepam
- Generic name (nonproprietary)
- diazepam
- Active ingredients
- Diazepam — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071321
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 61919-409_47e14ab4-5eb5-67c7-e063-6394a90a1e4bSPL ID 47e14ab4-5eb5-67c7-e063-6394a90a1e4bSPL set ID 4b0c9c0a-4274-4d56-a7a4-bc497916469cRxCUI 197589, 197591UNII Q3JTX2Q7TU
- Pharmacologic class
- Benzodiazepine
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
N461919040902followed by a unit qualifier and the quantityPackage 61919-0409-02. 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)
INDICATIONS & USAGE SECTION Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraple…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071321
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 |
|---|---|---|---|---|
| Diazepam | Diazepam 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1713 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Proficient Rx LP | 63187-173 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0172-3926 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-1913 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-970 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4770 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1523 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-2249 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1584 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Coupler LLC | 67046-0943 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-533 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-3926 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-270 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4922 |