0378-4124 : Albuterol 8 mg 12 Hr Extended Release Tablet


NDC0378-4124
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Albuterol Sulfate
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA078092
Rev. Date: 


Appearance:


Markings: M;24
Shapes:  Round
Colors:  Blue
Size (mm): 6
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

M 24: (0378-4124) Albuterol 8 mg 12 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
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:

  • 0378-4124-01: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4124‑01)
  • 0378-4124-05: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4124‑05)

Active Ingredients:

  • Albuterol Sulfate

Dosage Strength:

  • 8 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polydextrose
  • Polyethylene Glycol
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Triacetin
  • Xanthan Gum
  • Fd&c Blue No. 2
  • Fd&c Yellow No. 6

Pharmaceutical Classes:

  • Adrenergic beta2-Agonists [MoA]
  • beta2-Adrenergic Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 0378-4122 Albuterol 4 mg 12 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-6990 Albuterol Sulfate .83 mg/ml Respiratory (Inhalation) Solution by Mylan Pharmaceuticals Inc.
  • 0378-6991 Albuterol Sulfate .75 mg/3ml Respiratory (Inhalation) Solution by Mylan Pharmaceuticals Inc.
  • 0378-6992 Albuterol Sulfate 1.5 mg/3ml Respiratory (Inhalation) Solution by Mylan Pharmaceuticals Inc.
  • 0378-7057 Albuterol Sulfate .63 mg/3ml Respiratory (Inhalation) Solution by Mylan Pharmaceuticals Inc.
  • 0378-7058 Albuterol Sulfate 1.25 mg/3ml Respiratory (Inhalation) Solution by Mylan Pharmaceuticals Inc.
  • 0378-8270 Albuterol Sulfate 2.5 mg/3ml Respiratory (Inhalation) Solution by Mylan Pharmaceuticals, Inc.
  • 0054-0742 Albuterol Sulfate 90 ug/1 Respiratory (Inhalation) Aerosol, Metered by Hikma Pharmaceuticals USA Inc.
  • 0093-0661 Albuterol Sulfate 2 mg/5ml Oral Syrup by Teva Pharmaceuticals USA Inc
  • 0254-1007 Albuterol Sulfate 108 ug/1 Respiratory (Inhalation) Aerosol, Metered by Par Pharmaceutical Inc.
  • 0472-0825 Albuterol Sulfate 2 mg/5ml Oral Syrup by Actavis Pharma, Inc.
  • 0487-0301 Albuterol Sulfate .75 mg/3ml Respiratory (Inhalation) Solution by Nephron Pharmaceuticals Corporation
  • 0487-9501 Albuterol Sulfate 2.5 mg/3ml Respiratory (Inhalation) Solution by Nephron Pharmaceuticals Corporation
  • 0487-9901 Albuterol Sulfate 2.5 mg/.5ml Respiratory (Inhalation) Solution by Nephron Pharmaceuticals Corporation
  • 0487-9904 Albuterol Sulfate 1.5 mg/3ml Respiratory (Inhalation) Solution by Nephron Pharmaceuticals Corporation
  • 0591-3467 Albuterol Sulfate .63 mg/3ml Intrabronchial Solution by Watson Laboratories, Inc.
  • 0591-3468 Albuterol Sulfate 1.25 mg/3ml Intrabronchial Solution by Watson Laboratories, Inc.
  • 0591-3797 Albuterol Sulfate 2.5 mg/3ml Intrabronchial Solution by Watson Laboratories, Inc.
  • 0603-1008 Albuterol Sulfate 2 mg/5ml Oral Solution by Qualitest Pharmaceuticals
  • 0781-7155 Albuterol Sulfate 2.5 mg/3ml Respiratory (Inhalation) Solution by Sandoz Inc.
  • More related products ...

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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.