43353-278 : Diazepam 5 mg Oral Tablet


NDC: 43353-278
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product Type: Human Prescription Drug
Drug Name:  Diazepam
Dosage Form: Oral Tablet
Application #: ANDA071135
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: DAN;5619;5
Shapes:  Round
Colors:  Yellow
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.

DAN 5619 5: (0591-5619) Diazepam 5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 43353-278-15: 15 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑15)
  • 43353-278-20: 20 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑20)
  • 43353-278-30: 30 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑30)
  • 43353-278-45: 45 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑45)
  • 43353-278-53: 60 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑53)
  • 43353-278-55: 75 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑55)
  • 43353-278-60: 90 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑60)
  • 43353-278-70: 120 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑70)
  • 43353-278-75: 150 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑75)
  • 43353-278-80: 180 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑80)
  • 43353-278-90: 240 TABLET IN 1 BOTTLE, PLASTIC (43353‑278‑90)

Active Ingredients:

  • Diazepam

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • D&c Yellow No. 10

Pharmaceutical Classes:

  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]

Related Products:

Based on records with the same trade name.
  • 43353-276 Diazepam 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 43353-281 Diazepam 2 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 43353-783 Diazepam 5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 43353-820 Diazepam 2 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 43353-825 Diazepam 2 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 67544-019 Diazepam 5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 67544-020 Diazepam 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 67544-720 Diazepam 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-270 Diazepam 5 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-424 Diazepam 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-427 Diazepam 10 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-459 Diazepam by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-460 Diazepam by Aphena Pharma Solutions - Tennessee, LLC
  • 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.
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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.