51079-020 : Budesonide 3 mg 24 Hr Extended Release Enteric Coated Capsule


NDC: 51079-020
Labeler: Udl Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Budesonide
Dosage Form: Oral Capsule
Application #: ANDA090410
Rev. Date: 


Appearance:


Markings: MYLAN;7155
Shapes:  Capsule
Colors:  Red
Size (mm): 18
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.

MYLAN 7155: (0378-7155) Budesonide 3 mg 24 Hr Extended Release Enteric Coated Capsule by Udl Laboratories, 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:

  • 51079-020-03: 30 BLISTER PACK IN 1 BOX, UNIT‑DOSE (51079‑020‑03) > 1 CAPSULE IN 1 BLISTER PACK (51079‑020‑01)

Active Ingredients:

  • Budesonide

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Acetyltributyl Citrate
  • Silicon Dioxide
  • Crospovidone
  • Dimethicone
  • Ethylcelluloses
  • Fd&c Red No. 40
  • Gelatin
  • Lactose Monohydrate
  • Magnesium Stearate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Polysorbate 80
  • Sodium Hydroxide
  • Sodium Lauryl Sulfate
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate
  • Ferrosoferric Oxide
  • D&c Yellow No. 10
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Propylene Glycol
  • Shellac

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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
  • 11822-1700 Budesonide 32 ug/1 Nasal Spray, Metered by Rite Aid
  • 11822-6000 Budesonide 32 ug/1 Nasal Spray, Metered by Rite Aid
  • 16714-829 Budesonide 3 mg Oral Capsule, Coated Pellets by Northstar Rx LLC.
  • 21130-710 Budesonide 32 ug/1 Nasal Spray, Metered by Safeway
  • 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.