Prescription drug · ANDA
Diazepam NDC 76420-533
Diazepam 5 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-533-00 | 76420053300 | 1000 TABLET in 1 BOTTLE (76420-533-00)Marketed from Jan 27, 2025 | |
| 76420-533-01 | 76420053301 | 100 TABLET in 1 BOTTLE (76420-533-01)Marketed from Jan 14, 2023 | |
| 76420-533-02 | 76420053302 | 2 TABLET in 1 BOTTLE (76420-533-02)Marketed from Jan 27, 2025 | |
| 76420-533-03 | 76420053303 | 3 TABLET in 1 BOTTLE (76420-533-03)Marketed from Jan 27, 2025 | |
| 76420-533-05 | 76420053305 | 5 TABLET in 1 BOTTLE (76420-533-05)Marketed from Jan 27, 2025 | |
| 76420-533-10 | 76420053310 | 10 TABLET in 1 BOTTLE (76420-533-10)Marketed from Jan 27, 2025 | |
| 76420-533-20 | 76420053320 | 20 TABLET in 1 BOTTLE (76420-533-20)Marketed from Jan 27, 2025 | |
| 76420-533-30 | 76420053330 | 30 TABLET in 1 BOTTLE (76420-533-30)Marketed from Mar 8, 2024 | |
| 76420-533-55 | 76420053355 | 500 TABLET in 1 BOTTLE (76420-533-55)Marketed from Jan 27, 2025 | |
| 76420-533-60 | 76420053360 | 60 TABLET in 1 BOTTLE (76420-533-60)Marketed from Mar 8, 2024 | |
| 76420-533-90 | 76420053390 | 90 TABLET in 1 BOTTLE (76420-533-90)Marketed from Mar 8, 2024 |
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
- Asclemed USA, Inc.
- 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 76420-533_2cb3e981-e5b2-9d49-e063-6394a90abfbdSPL ID 2cb3e981-e5b2-9d49-e063-6394a90abfbdSPL set ID 32e7bfa1-6060-4041-a0e5-249cacb84ebcRxCUI 197589, 197590, 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
N476420053300followed by a unit qualifier and the quantityPackage 76420-0533-00. 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 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 tablets 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 paraplegia), at…
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 | Direct_Rx | 61919-409 |
| 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 | 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 |