Prescription drug · ANDA
Diazepam NDC 61919-906
Diazepam 10 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-906-02 | 61919090602 | 2 TABLET in 1 BOTTLE (61919-906-02)Marketed from Nov 1, 2016 | |
| 61919-906-05 | 61919090605 | 5 TABLET in 1 BOTTLE (61919-906-05)Marketed from Sep 25, 2019 | |
| 61919-906-10 | 61919090610 | 10 TABLET in 1 BOTTLE (61919-906-10)Marketed from Nov 1, 2016 | |
| 61919-906-30 | 61919090630 | 30 TABLET in 1 BOTTLE (61919-906-30)Marketed from Nov 1, 2016 | |
| 61919-906-60 | 61919090660 | 60 TABLET in 1 BOTTLE (61919-906-60)Marketed from Nov 1, 2016 | |
| 61919-906-90 | 61919090690 | 90 TABLET in 1 BOTTLE (61919-906-90)Marketed from Nov 1, 2016 |
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
- Direct_RxNDC labeler code 61919
- 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 61919-906_47e14ab4-5eb5-67c7-e063-6394a90a1e4bSPL ID 47e14ab4-5eb5-67c7-e063-6394a90a1e4bSPL set ID 4b0c9c0a-4274-4d56-a7a4-bc497916469cRxCUI 197589, 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
N461919090602followed by a unit qualifier and the quantityPackage 61919-0906-02. 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 & USAGE SECTION 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 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 paraple…
Excerpt only. Read the full label for complete information.
About NDC 61919-906
- What is NDC 61919-906?
- 61919-906 is the product NDC for Diazepam, Diazepam 10 mg/1 tablet, listed with the FDA by Direct_Rx. It has 6 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?
- Direct_Rx, NDC labeler code 61919. 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 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-026 | 87441-0026-01 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-025 | 87441-0025-01 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Coupler LLC | 67046-0944 | 67046-0944-03 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Coupler LLC | 67046-0943 | 67046-0943-03 |
| Diazepam | Diazepam 5 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9762 | 00404-9762-10 |
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. | 70518-0014 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Coupler LLC | 67046-0944 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Proficient Rx LP | 63187-544 |
| 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 | Asclemed USA, Inc. | 76420-784 |
| 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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0120 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4829 |