Prescription drug · ANDA
Diazepam NDC 51079-286
Diazepam 10 mg/1 · Tablet · Oral · Mylan Institutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-286-20 | 51079028620 | 100 BLISTER PACK in 1 CARTON (51079-286-20) / 1 TABLET in 1 BLISTER PACK (51079-286-01)Marketed from Oct 31, 1997 |
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
- Mylan Institutional Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070325
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 51079-286_3a39f676-7a52-3d33-e063-6294a90a4123SPL ID 3a39f676-7a52-3d33-e063-6294a90a4123SPL set ID b326c66d-5762-4d16-933c-619fa2088ccdRxCUI 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
N451079028620followed by a unit qualifier and the quantityPackage 51079-0286-20. 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 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 tablets 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 cerebral palsy …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070325
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 | Bryant Ranch Prepack | 71335-2239 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Safecor Health, LLC | 48433-028 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | Safecor Health, LLC | 48433-027 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Safecor Health, LLC | 48433-029 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2247 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Direct_Rx | 72189-552 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5554 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-4047 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | Direct_rx | 72189-570 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0345 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2306 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8462 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8466 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-025 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-026 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-284 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-285 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0496 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0477 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0512 |
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