Prescription drug · ANDA
Diazepam NDC 63187-544
Diazepam 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-544-06 | 63187054406 | 6 TABLET in 1 BOTTLE (63187-544-06)Marketed from Dec 17, 2019 | |
| 63187-544-15 | 63187054415 | 15 TABLET in 1 BOTTLE (63187-544-15)Marketed from Dec 1, 2018 | |
| 63187-544-20 | 63187054420 | 20 TABLET in 1 BOTTLE (63187-544-20)Marketed from Dec 1, 2018 | |
| 63187-544-30 | 63187054430 | 30 TABLET in 1 BOTTLE (63187-544-30)Marketed from Dec 1, 2018 | |
| 63187-544-60 | 63187054460 | 60 TABLET in 1 BOTTLE (63187-544-60)Marketed from Dec 1, 2018 | |
| 63187-544-90 | 63187054490 | 90 TABLET in 1 BOTTLE (63187-544-90)Marketed from Dec 1, 2018 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071322
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 63187-544_aeef8cde-a187-453e-b7fb-e179493ff427SPL ID aeef8cde-a187-453e-b7fb-e179493ff427SPL set ID f8d26f65-a015-4bfc-b1fa-8595d72af48cRxCUI 197589UNII Q3JTX2Q7TUUPC 0363187544300
- 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
N463187054406followed by a unit qualifier and the quantityPackage 63187-0544-06. 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 AND USAGE Diazepam Tablets USP 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 USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets USP are 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 cer…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071322
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 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0162 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-424 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-1726 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0172-3927 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0444 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-987 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-784 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4829 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Direct_Rx | 61919-906 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Coupler LLC | 67046-0944 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0120 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0014 |