49884-501 : Budesonide 3 mg 24 Hr Extended Release Enteric Coated Capsule


NDC: 49884-501
Labeler: Par Pharmaceutical Inc.
Product Type: Human Prescription Drug
Drug Name:  Budesonide
Dosage Form: Oral Capsule
Application #: NDA021324
Rev. Date: 


Appearance:


Markings: ENTOCORTEC;3mg
Shapes:  Capsule
Colors:  Gray
Size (mm): 7
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.

ENTOCORTEC 3mg: (49884-501) Budesonide 3 mg 24 Hr Extended Release Enteric Coated Capsule by Par Pharmaceutical 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:

  • 49884-501-01: 100 CAPSULE IN 1 BOTTLE (49884‑501‑01)

Active Ingredients:

  • Budesonide

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Ethylcelluloses
  • Acetyltributyl Citrate
  • Methacrylic Acid
  • Triethyl Citrate
  • Polysorbate 80
  • Talc
  • Gelatin
  • Ferrosoferric Oxide
  • Titanium Dioxide
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Sucrose

Pharmaceutical Classes:

  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]

Related Products:

Based on records with the same trade name.
  • 49884-157 Budesonide 32 ug/1 Nasal Spray, Metered by Par Pharmaceutical Inc.
  • 0093-6815 Budesonide .25 mg/2ml Respiratory (Inhalation) Suspension by Teva Pharmaceuticals USA Inc
  • 0093-6816 Budesonide .5 mg/2ml Respiratory (Inhalation) Suspension by Teva Pharmaceuticals USA Inc
  • 0093-6817 Budesonide 1 mg/2ml Respiratory (Inhalation) Suspension by Teva Pharmaceuticals USA Inc
  • 0186-1073 Budesonide 32 ug/1 Nasal Spray, Metered by Astrazeneca Lp
  • 0363-0048 Budesonide 32 ug/1 Nasal Spray, Metered by Walgreens
  • 0378-4500 Budesonide 9 mg Oral Tablet, Film Coated, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-7155 Budesonide 3 mg 24 Hr Extended Release Enteric Coated Capsule by Mylan Pharmaceuticals Inc.
  • 0487-9601 Budesonide .25 mg/2ml Respiratory (Inhalation) Inhalant by Nephron Pharmaceuticals Corporation
  • 0487-9701 Budesonide .5 mg/2ml Respiratory (Inhalation) Inhalant by Nephron Pharmaceuticals Corporation
  • 0536-1112 Budesonide 32 ug/1 Nasal Spray, Metered by Rugby Laboratories
  • 0574-9855 Budesonide 3 mg Oral Capsule by Paddock Laboratories, LLC
  • 0591-2510 Budesonide 9 mg Oral Tablet, Film Coated, Extended Release by Actavis Pharma, Inc.
  • 0781-7515 Budesonide .25 mg/2ml Respiratory (Inhalation) Suspension by Sandoz Inc
  • 0781-7516 Budesonide .5 mg/2ml Respiratory (Inhalation) Suspension by Sandoz Inc
  • 0781-7517 Budesonide 1 mg/2ml Respiratory (Inhalation) Suspension by Sandoz Inc
  • 0904-7166 Budesonide 3 mg Oral Capsule, Delayed Release by Major Pharmaceuticals
  • 0904-7313 Budesonide 3 mg Oral Capsule, Coated Pellets by Major Pharmaceuticals
  • 11822-1700 Budesonide 32 ug/1 Nasal Spray, Metered by Rite Aid
  • 11822-6000 Budesonide 32 ug/1 Nasal Spray, Metered by Rite Aid
  • More related products ...

NDC QR Code

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NDC 49884-501 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.