Prescription drug · ANDA
Diazepam NDC 59651-653
Diazepam 5 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-653-01 | 5965106530159651065301 | 100 TABLET in 1 BOTTLE (59651-653-01)Marketed from Dec 14, 2023 | |
| 59651-653-05 | 5965106530559651065305 | 500 TABLET in 1 BOTTLE (59651-653-05)Marketed from Dec 14, 2023 | |
| 59651-653-99 | 5965106539959651065399 | 1000 TABLET in 1 BOTTLE (59651-653-99)Marketed from Dec 14, 2023 |
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
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217843
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 59651-653_2f799120-0d08-47cd-8183-a98f0267c845SPL ID 2f799120-0d08-47cd-8183-a98f0267c845SPL set ID 2f799120-0d08-47cd-8183-a98f0267c845RxCUI 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
N459651065301followed by a unit qualifier and the quantityPackage 59651-0653-01. 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.
About NDC 59651-653
- What is NDC 59651-653?
- 59651-653 is the product NDC for Diazepam, Diazepam 5 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diazepam.
- What is the active ingredient?
- Diazepam.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diazepam?
- 118 other product NDCs are listed under this name. See all Diazepam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diazepam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diazepam | Diazepam 5 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-175 | 72572-0175-10 |
| Diazepam | Diazepam 10 mg/2mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-121 | 43066-0121-10 |
| Diazepam | Diazepam 20 mg/4mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-123 | 43066-0123-10 |
| Diazepam | Diazepam 10 mg/2mL | Injection, SolutionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4704 | 70518-4704-00 |
| Diazepam | Diazepam 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6283 | 00641-6283-25 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-025 | 87441-0025-01 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-026 | 87441-0026-01 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Coupler LLC | 67046-0943 | 67046-0943-03 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Coupler LLC | 67046-0944 | 67046-0944-03 |
| Diazepam | Diazepam 5 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9762 | 00404-9762-10 |
Other NDCs under ANDA 217843
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 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-652 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-654 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3682 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc | 68071-3686 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | ASCLEMED USA INC. | 76420-314 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | ASCLEMED USA INC. | 76420-315 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | ASCLEMED USA INC. | 76420-316 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0511 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Proficient Rx LP | 82804-186 |