68774-400 : Albuterol 4 mg 12 Hr Extended Release Tablet


NDC: 68774-400
Labeler: Dava Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Albuterol Sulfate ER
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA076130
Rev. Date: 


Appearance:


Markings: V;4
Shapes:  Round
Colors:  Green
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.

V 4: (68774-400) Albuterol 4 mg 12 Hr Extended Release Tablet by Dava 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:

  • 68774-400-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (68774‑400‑01)

Active Ingredients:

  • Albuterol Sulfate

Dosage Strength:

  • 4 mg

Inactive Ingredients:

  • Calcium Sulfate
  • Carnauba Wax
  • Ethylcelluloses
  • Ferrosoferric Oxide
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Polyethylene Glycols
  • Propylene Glycol
  • Shellac
  • Stearic Acid
  • Titanium Dioxide
  • Triacetin
  • D&c Yellow No. 10
  • Fd&c Blue No. 1

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 68774-401 Albuterol 8 mg 12 Hr Extended Release Tablet by Dava 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.
  • 0378-4122 Albuterol 4 mg 12 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-4124 Albuterol 8 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.
  • 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.
  • 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.