0378-0477 : Diazepam 10 mg Oral Tablet


NDC0378-0477
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Diazepam
Dosage Form: Oral Tablet
Application #: ANDA070325
Rev. Date: 
CSA Schedule: CIV (US) [1]


[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: MYLAN;477
Shapes:  Round
Colors:  Green
Size (mm): 8
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 0378-0477-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0378‑0477‑01)
  • 0378-0477-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0378‑0477‑05)

Active Ingredients:

  • Diazepam

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Starch, Corn
  • Sodium Lauryl Sulfate
  • Fd&c Blue No. 1
  • D&c Yellow No. 10

Pharmaceutical Classes:

  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]

Related Products:

Based on records with the same trade name.
  • 0378-0271 Diazepam 2 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-0345 Diazepam 5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0054-3188 Diazepam 5 mg/5ml Oral Solution by Roxane Laboratories, Inc
  • 0054-8207 Diazepam 5 mg/5ml Oral Solution by Roxane Laboratories, Inc
  • 0093-6137 Diazepam 2.5 mg/.5ml Rectal Gel by Teva Pharmaceuticals USA Inc
  • 0093-6138 Diazepam 10 mg/2ml Rectal Gel by Teva Pharmaceuticals USA Inc
  • 0093-6139 Diazepam 20 mg/4ml Rectal Gel by Teva Pharmaceuticals USA Inc
  • 0121-0905 Diazepam 5 mg/5ml Oral Solution by Pharmaceutical Associates, Inc.
  • 0172-3925 Diazepam 2 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0172-3926 Diazepam 5 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0172-3927 Diazepam 10 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0179-1429 Diazepam 5 mg/1 Oral Tablet by Kaiser Foundation Hospitals
  • 0179-1431 Diazepam 10 mg/1 Oral Tablet by Kaiser Foundation Hospitals
  • 0404-9848 Diazepam 5 mg/ml Intramuscular; Intravenous Injection, Solution by Henry Schein, Inc.
  • 0404-9849 Diazepam 5 mg/ml Intramuscular; Intravenous Injection, Solution by Henry Schein, Inc.
  • 0409-1273 Diazepam 5 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
  • 0409-3213 Diazepam 5 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
  • 0527-1767 Diazepam 5 mg/5ml Oral Solution by Lannett Company, Inc.
  • 0527-1768 Diazepam 5 mg/ml Oral Solution, Concentrate by Lannett Company, Inc.
  • 0591-5619 Diazepam 5 mg Oral Tablet by Watson Laboratories, Inc.
  • More related products ...

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.