Prescription drug · ANDA
Diazepam NDC 43353-825
Diazepam 2 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-825-30 | 43353082530 | 30 TABLET in 1 BOTTLE (43353-825-30)Marketed from Mar 8, 2013 | |
| 43353-825-53 | 43353082553 | 60 TABLET in 1 BOTTLE (43353-825-53)Marketed from Mar 8, 2013 | |
| 43353-825-60 | 43353082560 | 90 TABLET in 1 BOTTLE (43353-825-60)Marketed from Mar 8, 2013 | |
| 43353-825-70 | 43353082570 | 120 TABLET in 1 BOTTLE (43353-825-70)Marketed from Mar 8, 2013 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071307
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 43353-825_ab1a1c72-dcae-47ba-8f0e-aefb9b5143a0SPL ID ab1a1c72-dcae-47ba-8f0e-aefb9b5143a0SPL set ID b29916fb-1781-4112-9c3e-45478754d638RxCUI 197590UNII 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
N443353082530followed by a unit qualifier and the quantityPackage 43353-0825-30. 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 43353-825
- What is NDC 43353-825?
- 43353-825 is the product NDC for Diazepam, Diazepam 2 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 071307
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 | Bryant Ranch Prepack | 63629-2948 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-840 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-783 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0172-3925 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-3925 |
| Diazepam | Diazepam 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-0195 |